Alembic


Regtech India


Advantmed Nasik


Aculife Healthcare


Straits Research Pune


Centaur Pune


Wockhardt


Zydus


Felix Genric


Atvantmed


Sudeep Pharma


Aarti Pharmalab


FDC


Alembic Pharma


Macleods Pharma


Cipla


Chirok Healthcare


DK Pharma


Biophore


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Emcure Pune walkin


Sun Pharma Female walkin


HETERO


Supriya Life Science Ltd


Aster DM Healthcare


Glenmark


Hetero Fresher Hiring


Eugia


Synergen Bio Pune


Emcure Pune Walkin


Job Fair Ghatkopar Mumbai


MSN


Brassica


Flamingo F&D walkin


Flamingo F&D walkin


Tech Mahindra Pune


Flamingo Pharma


Honour Lab


Aurobindo


Titan


Titan


Bio Plus Life Science


Strides


Hetero


Hetero


Vee Healthtech


Titan Pharma


Apotex


Trainee - Quality Stability Data

About Apotex Inc.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: www.apotex.com.

 

Job Summary

  • Responsible to summarize and review stability data to ensuring that Apotex commercial products’ shelf lives are supported.
  • Provide required stability data to customers for their product compliance files.

Job Responsibilities

  • Prepare Stability Summary Reports within compliance time frame.
  • To ensure summary reports are correct and complete as per Apotex procedures.
  • Prepare and provide summary reports for special projects and product evaluations requested by internal or external customers.
  • Review Stability data from third party affiliates for compliance.
  • Perform Stability Impact Assessment for out-of-trend results obtained at release for drug product as per approved procedures.
  • Review and evaluate Stability data for the product to ensure that no significant trends are developing that warrants attention and that the approved shelf life continues to be justified.
  • Provide Annual Stability Review contribution packages to QA Product Review group for the Annual Product Quality Review (APQR). Notify Assistant Manager of any adverse trends detected.
  • Works as an effective team member to meet department goals, sharing knowledge with team members.
  • Maintain compliance to all health and safety standards, Good Manufacturing Practices, Good Documentation Practices and regulatory requirements. Responsible and accountable for compliance with all aspects of the local safety regulations, as well as Apotex’s Health and Safety policies, and Safe Work Procedures.
  • Performs all work in support of our Corporate Values of Courage, Collaboration, Passion and Perseverance; Demonstrates strong and visible support of our values.
  • Works in a safe manner collaborating as a team member to achieve all outcomes.
  • Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
  • Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
  • All other relevant duties as assigned.

 

Job Requirements

  • Education
    • Master’s Degree in Science / Pharmacy
  • Knowledge, Skills and Abilities:
    • Have good understanding of pharmaceutical Quality Control systems.
    • Demonstrated knowledge of Stability requirements.
    • Good interpersonal skills and results oriented team player.
    • Able to work with minimum supervision.
    • Communicate findings to the Assistant Manager, an escalate any critical issues arising from the Stability summary report.
    • Work as part on intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
    • Good written and verbal communication skills.
    • Experience with Microsoft Office applications an added advantage.

Application link:

https://careers.apotex.com/job/Mumbai-Trainee-Quality-Stability-Data-MH-400079/586337817/

IPCA Laboratories Ltd


Freshers: Walk-In Interview

M.Sc. (Biotechnology/Microbiology/Biochemistry/Life Sciences)

Date: Saturday, 23rd November 2024
Time: 9:30 am to 3 pm
Location: Ipca Laboratories Limited,
470, 471, 481, Sector 3,
Industrial Area, Pithampur,
Dist Dhar, Madhya Pradesh - 454775
Email: piyush.khichi@ipca.com

Google map location:
https://lnkd.in/djEEJ_-e

Cliantha Research


Regulatory Affairs Officer

Cliantha Research

0 - 2 years, 1.75-3 Lacs P.A.

Job description, Role & responsibilities

REGULATORY RELATED ACTIVITIES :

A. Review and finalization of DCGI required documentation for application in coordination with respective managers.

B. Responsible for BE-NOC, T-license applications & notifications submission to Drugs Controller General of India (DCGI) in coordination with respective managers.

C. To ensure proper query response in stipulated timelines for the submitted applications in coordination with respective managers.

D. To track the regulatory approvals on regular basis and place in common drive of all locations after downloading.

E. Responsible to maintain regulatory tracking sheet of all the submitted applications/approvals/notifications.

NOTE:

Looking for B.Pharma candidates with basic knowledge related to job profile only.

We are not considering M.pharma or any other qualification.

Employment Type: Full Time, Permanent

Education

UG: B.Pharma in Any Specialization

About company

Clinical Research Organization

Address:TP 86, FP 28/1, CLIANTHA CORPORATE , AHMEDABAD, Gujarat, India

Application link : https://www.naukri.com/job-listings-regulatory-affairs-officer-cliantha-research-ahmedabad-0-to-2-years-041024008565?src=sortby&sid=173150319038580_1&xp=14&px=1&nignbevent_src=jobsearchDeskGNB

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Reliance Life Sciences


Come and join in this enriching journey at Reliance Life Sciences!

Current Openings

  • Lateral Hiring: To join us please click here.
  • Young Professionals’ Program: Reliance Life Sciences is offering exciting opportunities in Manufacturing, Quality and R&D domains, for Graduates and Post Graduates (MSc / B. Pharm/ B.E. or B.Tech. in Biotechnology). Freshers interested to join us, can mail their resumes to careers@relbio.com.
Endo - Trainee Formulation Development


Trainee Formulation Development

  • India - Digha
  • Full time, Temporary
  • Posted 2 Days Ago
  • R001789

Job Description Summary

To assist the formulation development activity.

Job Description

  • To perform Formulation development assigned by HOD/Manager/Designee. 
  • To carry out the Literature search on APIs, patents, excipients, technologies for the development of formulation. SBOA review Innovator Product Characterization & planning formulation strategies along with assessment of QTPP & CQA.
  • To carry out Developmental lab trials and stability batches and optimization of formula & manufacturing process, performing the QbD /DoE based trials. Initiation and review documents related to filter validation.
  • To Prepare study protocols & reports including Stability, Scale up, MFR, Specifications of Product, data compilation etc.

Qualification: M. Pharm Fresher

Commitment to Diversity, Equity, and Inclusion:  

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

Apply through below link:

https://www.endo.com/careers/open-positions/job?jobid=R001789

 

Reliance Life Sciences


We Are Hiring – Join Our Quality Control Team in Nashik!

Are you passionate about ensuring the highest quality standards in pharmaceutical and biologics manufacturing?

We're expanding our Quality Control department and looking for experienced professionals to join our team in Nashik.

Open Positions:
1.    Team Lead I (Plasma Products)
o M.Sc. in Microbiology/Biotechnology/Biochemistry or B.Tech/M.Tech in Science
o  21-25 years of QC experience, leading teams of 10-25

2.    Team Lead I (Complex Biologics/Biosimilars)
o M.Sc. in Microbiology/Biotechnology/Biochemistry or B.Tech/M.Tech in Science
o  21-30 years of QC experience, leading teams of 20-40

3.    Senior Manager (Microbiology)
o M.Sc. in Microbiology
o  15-20 years of QC experience, leading microbiology teams of 5-15

4.    Senior Manager (Raw Material and Packing Material)
o M.Sc. in Chemistry
o  15-20 years of QC experience, leading teams of 10-25

5.    Analyst Quality Control
o M.Sc. in Microbiology/Biotechnology/Biochemistry/Chemistry
o  2-8 years of QC experience

All roles require expertise in GLP, aseptic practices, and hands-on experience with biologics or plasma products.

Ready to make a difference in global health? Apply now and join our innovative team!

For detailed job descriptions and to apply, visit: https://lnkd.in/dv5Dm-Vi
 

Endo - Regulatory Affairs Labeling - Assistant Manager


Regulatory Affairs Labeling - Assistant Manager

  • India - Digha
  • Full time, Regular
  • Posted 30+ Days Ago
  • R001269

Job Description Summary

Assistant Manager Regulatory Affairs Labeling will be responsible for Labeling activity/ Submissions for US market.

Job Description

  • Job Descriotion:
  • Preparation, review, and compilation of Module - I (Administrative / Labeling Section) as per e-CTD formats and complying the labeling requirements.
  • Prepare, assemble, review, and/or evaluate eCTD formal FDA submissions for ANDAs, as well as its amendments (Complete Response, Information Request and ECD), supplements (CBE, CBE - 30 and PAS) and annual reports.
  • Active participation in regulatory activities for allotted projects, query responses, post-approval changes and coordinate filing requirements of submissions within a time to ensure the compilation of quality regulatory submissions.
  • Ensure the electronic submission is accurate and complies as per the RTR, content & format of submission with current Agency’s requirements.
  • Daily Monitoring the Drugs@fda Site for RLD Labeling revisions, ensure the labeling is up to date for all under review and approved products; also based on changes will ensure in commercial implementation.
  • Ensure the NDC#; data base, Medication Guide / PIS’s distribution, Daily Med updation; identifying the revisions for the Annual Reportable Changes.
  • Communicate the Cross Functional team and vendor for the Artwork and Print proof approval to receive as per dimensions.
  • Ensure the Commercial Labeling free from Medication error.
  • Monitoring the Orange book cumulative monthly update for Patent and Exclusivities and ensure the Labeling, Patent & exclusivities for product accordingly by communicating the same to Legal group.
  • Follows and monitor Agency’s new guidance’s that may affect current and future ANDAs.
  • Review and improve the knowledge from SBIA Webinars and REdl Guidance’s
  • Preparation, review of new and revised departmental Standard Operating Procedures.
  • Ensure the submission have all the necessary documents and communicate the same.
  • Closely observe the REMS documents to align as per the Approved Labeling.
  • Monitoring the REMS@FDA to have proper labeling directions for patient guidance.
  • Also, ensure the post-approval submissions as per the committed timeline to ensure compliance.

 

Education and Experience:

M. Pharm/ M. Sc with 6-8 years relevant experience.

Commitment to Diversity, Equity, and Inclusion:  

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents

Apply Job through below link:

https://www.endo.com/careers/open-positions/job?jobid=R001269

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Reliance 14.10


our career journey."

Reliance Life Sciences Hiring for MSc Microbiology, Biotechnology and Biotechnology.

 

October 08, 2024

Reliance Life Sciences Hiring for MSc Microbiology, Biotechnology and Biotechnology.

 

 

 

We Are Hiring - Join Our Plasma Manufacturing and Quality Assurance Team!

About Reliance Life Sciences:

Reliance Life Sciences is a research-driven organization developing business opportunities in bio-therapeutics (plasma proteins, biosimilars and novel proteins), pharmaceuticals (later-generation, oncology generics), clinical research services, regenerative medicine (stem cells therapies) and molecular medicine. Reliance Life Sciences is part of the Promoter Group of Reliance Industries Limited.

We have launched five of the world’s first biosimilars, have the largest number of biosimilars in the market in India, and the highest number of biosimilars under development globally. It has the distinction of being the first integrated manufacturer of plasma proteins in South Asia. Reliance Life Sciences has catalyzed the emergence of regenerative medicine in the country, and has the highest experience with cord blood stem cell transplants in India. RLS is one of the few centres in the world offering a specialized range of tests in molecular medicine and molecular genetics.

Are you passionate about advancing global health through cutting-edge plasma technology? Join our innovative team and make a lasting impact in the field of biopharmaceuticals!

 

Plasma Manufacturing/Production:

Roles: Executive/Senior Executive/Deputy Manager

- Qualifications: M.Sc. (Biotechnology/Microbiology/ Biochemistry)

Experience: 2-10 years of experience with expertise in Upstream fractionation, Downstream Protein purification, Industrial Centrifuge, Industrial filtration and fill finish.

- Location: Navi Mumbai / Nashik

 

Plasma Quality Assurance:

- Roles: Executive/Senior Executive

- Qualifications: M.Sc. (Biotechnology/Microbiology/ Biochemistry)

- Experience: 2-10 years of experience with expertise in QMS, Quality Assurance activities, IPQA, Change control management, OOS and Deviation handling.

 

- Location: Navi Mumbai / Nashik

Take the next step in your career and help shape the future of medicine. Apply now to become a vital part of our dynamic Plasma Manufacturing and QA team! Click here

Teva


Regulatory Affairs Associate I

Date:  Oct 11, 2024

Location:  

Navi Mumbai, India, 400706

Company:  Teva Pharmaceuticals

Job Id:  58773

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

  • The Regulatory Affairs Associate is a project manager, (PM) responsible for the RA lifecycle management on Medis dossiers for Teva’s 3rd party client business (Medis), ensuring  information flow and provision of supportive documents reaches the clients
  • The PM is responsible for liaison with Teva’s 3rd party client business (Medis) supply chain, Teva site RA and other  relevant functions

How you’ll spend your day

  • Lifecycle management on specific products for Europe and international market
  • Responsible at all times that regulatory modules under Product Manager responsibility are up to date, in accordance with agreed procedure as applicable
  • Inform, prepare and submit variations either directly to authorities or to Teva’s 3rd party client business (Medis)
  • Follow up on variation submissions, timelines and approvals, in accordance with agreed procedure as applicable
  • Compile answers to any deficiency questions from authorities or clients
  • Ensure outcomes of variations are communicated in timely manner and databases/lists are up to date at all times, in accordance with agreed procedure  as applicable
  • Regular status updates to management
  • Goal setting and follow up together with his/her supervisor
  • Professional communications with both internal and external stakeholders
  • Work on other specialized projects as defined by managers of RA

Your experience and qualifications

  • M Pharm/ MSc: 2 to 3 years of experience in RA
  • B Pharm/BSc: 3 to 5 years of experience in RA
  • Minimum one year relevant experience in EU.

Personal Characteristics

  • Good organization skills
  • Good communication and presentation skills
  • Good written and verbal knowledge in English
  • Strategic thinking and flexibility to adapt to changes
  • Good team player
  • Good computer skills
  • Proactive way of working and able to work independently

Reports To

Manager Regulatory Affairs

Application job link (if link is not opening, copy this link and open in new google window)

https://careers.teva/job/Navi-Mumbai-Regulatory-Affairs-Associate-I-Indi-400706/1221995500/

 

Mascot Spincotrol


Clinical Research Associate (CRA)
Mascot Spincontrol India Pvt Ltd
Location: Mumbai, Maharashtra
Job Type: Full-Time

Qualifications:

Experience: 0-1 year
Principal Duties and Responsibilities:

Obtain screening consent from volunteers
Record demographics and fill out habit questionnaires
Maintain screening logs and update the volunteer database
Verify age proof, address proof, and photographs of volunteers
Record details in volunteer enrollment forms and questionnaires
Monitor humidity, temperature, and acclimatization of volunteers
Ensure study flow and obtain informed consent from volunteers
Record and maintain study logs and perform lactic acid stinging tests
Gather proscription/restriction information and subject self-evaluation
Ensure proper data entry, verification, and operation of instruments
Check the quality of CRFs and related documents, ensuring completeness
Archive study-related documents and maintain the registration database
Joining: Immediate

Application:

Send your CV, cover letter, and references (if any) to:

Email: hr@mascotspincontrol.in or nisha@mascotspincontrol.in

 

Forwarded as received 

Chem-Tech Laboratories Private Limited Pune


URGENT JOB OPENING 
Calling all Male and Female fresher graduates in MSc Chemistry at Pune
Company: Chem-Tech Laboratories Private Limited
Walk-in Date: Oct 4th and Oct 5th
Position: Trainee Analytical Chemist
Are you passionate about analytical chemistry? Chem-Tech Laboratories is offering exciting opportunities for freshers to kickstart their career journey! Don't miss this chance to showcase your skills and expertise in a dynamic work environment.

Requirements:
MSc in Analytical and Organic Chemistry
- Strong analytical skills
- Attention to detail
- Excellent communication skills

Location: Chem-Tech Laboratories Private Limited S/N 22 Parvati Industrial Area Pune Satara Road Swargate Pune 411009
Time: 10.00 am to 12.00pm
Bring your resume and enthusiasm! Join us and be part of a team dedicated to scientific excellence. See you there!

Stanex


Stanex Drugs and Chemicals Pvt. Ltd is a prominent player in the pharmaceutical and chemicals industry, dedicated to enhancing health and well-being through innovative solutions. With a strong commitment to quality and compliance, Stanex strives to meet the evolving needs of healthcare professionals and patients alike. The company’s focus on research and development ensures that it remains at the forefront of the industry, providing cutting-edge products that adhere to the highest standards of safety and efficacy.

Responsibilities in Job
As a part of the Regulatory Affairs (RA) Department at Stanex, the key responsibilities include:

Regulatory Documentation: Preparing and reviewing regulatory submissions, including INDs, NDAs, and other compliance documents.
Guideline Compliance: Ensuring that all products comply with national and international regulations and guidelines set by regulatory authorities.
Collaboration: Working closely with cross-functional teams, including research, quality assurance, and production, to ensure seamless communication and compliance throughout the product lifecycle.
Regulatory Strategy: Assisting in the development of regulatory strategies that align with company goals and facilitate product approvals.
Monitoring Changes: Keeping abreast of changes in regulatory requirements and advising the team on necessary adjustments to policies and procedures.
Qualifications
To qualify for a position in the RA Department at Stanex, candidates should possess:

Educational Background: A Master’s degree in Pharmacy (M. Pharm), B.pharm, Msc is essential for this role.
Freshers Welcome: This position is open to fresh graduates
Skills
Candidates should ideally demonstrate the following skills:


Attention to Detail: Strong analytical skills and a meticulous approach to documentation and compliance tasks.
Communication Skills: Excellent verbal and written communication skills to effectively convey complex regulatory information.
Team Player: Ability to collaborate effectively with various teams across the organization.
Problem-Solving Skills: Aptitude for identifying regulatory challenges and proposing viable solutions.
Adaptability: Willingness to learn and adapt to the fast-paced and changing environment of regulatory affairs.
How to Apply
If you are a recent M. Pharm graduate looking to kick-start your career in regulatory affairs, Stanex Drugs and Chemicals Pvt. Ltd invites you to apply! To submit your application, send your resume directly to the HR department via WhatsApp at +91 91542 62431

Emmes


Emmes Group is dedicated to advancing clinical research and improving patient outcomes through innovation. With over 47 years of experience, Emmes is a leader in clinical research, serving both public-private partnerships and commercial biopharma. They specialize in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience. As an Associate TMF (Trial Master File) Specialist, you will play a key role in maintaining and organizing TMF documents while ensuring compliance with industry guidelines.

Primary Purpose
The Associate TMF Specialist is responsible for uploading, indexing, and maintaining TMF documents within an eTMF (electronic Trial Master File) system, ensuring compliance with SOPs, ICH/GCP guidelines, and TMF best practices.

Key Responsibilities

  • Act as an SME (Subject Matter Expert) on eTMF features related to TMF operations, document filing, and processes.
  • Follow the TMF Plan/Index, ensuring the collection of documents aligns with the plan.
  • Ensure compliance with Good Clinical Practice (GCP) guidelines and the TMF Reference Model.
  • Contribute to the development of SOPs, quality management reports, and quality control (QC)/quality assurance (QA) activities.
  • Support the implementation of Veeva Vault eTMF system features with the Clinical Systems Manager.
  • Participate in process streamlining and automation (e.g., VBA macros, Robotic Process Automation, AI/ML).
  • Maintain the TMF lifecycle, including report generation and document tracking.

Qualifications

  • Bachelor’s degree (preferably in a scientific discipline).
  • 0 to 3 years of experience in Clinical Operations and TMF filing.
  • Knowledge of eTMF applications and filing procedures (experience with Veeva is a plus).
  • Strong organizational, planning, analytical, and problem-solving skills.
  • Knowledge of GCP, TMF regulations, and the TMF Reference Model.
  • Experience in NIH-sponsored clinical programs is a bonus.
  • Ability to handle competing priorities and work in high-pressure environments.
  • Strong communication skills and fluency in English.

Skills & Competencies

  • High attention to detail and accuracy.
  • Ability to build positive relationships with team members and management.
  • Self-motivated and results-driven, with a strong initiative.

 

Apply on : https://careers.emmes.com/globalcareers/jobs/2273?lang=en-us

Zim Lab Nagpur


Belstar Microfinance Ltd.

We are welcoming energetic and enthusiastic candidates for Sales Officer Position

Location:- Akola, Murtijapur, Malkapur, Khamgaon,
Jalgaon Jamod, Sindkhed Raja, Wardha, Hinganghat,

Yavatmal, Ralegaon, Nagpur Savner, Umred.

Education – 10th /12th / Graduation
◆Age upto 30
◆ Experience :- Fresher/ Experience

For below position

Sales Officer Education 10/12 or Graduation salary upto 18K Fresher /Experience

Petrol allowance +PF+ Attractive incentives + Group Insurance+ Health Insurance

Note:- Only Immediate Jonier or One Month Notice period   Interested Candidates send your Resume      Yash Mehare (HR) :- 8805691341



Job Title: Production Trainee
Department: Production
Location: MIDC Kalmeshwar, Nagpur, Maharashtra
Eligibility:

Education: B.Pharm (Bachelor of Pharmacy)
Experience: Freshers welcome to apply!
Walk-In Interview Details:

Date: 29/09/2024
Time: 10 am – 5 pm
Venue: ZIM Laboratories Ltd, MIDC Kalmeshwar, Maharashtra
This is a great opportunity to gain hands-on experience in pharmaceutical manufacturing and launch your career in the industry.


For more details, contact us at careers@zimlab.in