Reports daily status to Site QA In-charge. Preparation/checking/review of QA SOPs and checking of other departmental SOPs. Authorise to sign all the issuance documents by QA. Line clearance activities. Review of various executed records, review and checking of Validation Protocols & Reports. Review of Analytical data (ADS, ATR and CoA) along with audit trail of software and its traceability. Review of analytical test data sheets, executed BPCRs and release of batch. Review of electronic data of ADS (like empower3 and Standalone instruments…etc.) Control, issue, distribution, retrieval of documents and destruction of obsolete document (controlled copy), recording etc. Handling of Change Control, Deviations and CAPA and OOS activities. Handling of validations, re-validations, qualification, re-qualification & calibrations. Carryout validations in coordination with the concerned production personnel / QC personnel / Engineering personnel. Monitor the trends of process, product quality and initiate corrective and preventive actions as and when required. Stability monitoring and trend study. Releasing or rejecting APIs/Intermediates/Raw Materials/Packing Materials. Maintenance and compliance of the quality system documents. Initiate continuous improvements in the quality systems. Maintaining the quality standards as mentioned in the quality policy manual. Updating of guidelines of IMS systems, WHO standards and other Local FDA regulations. Co-ordination of TTD with R&D personnel. Ensuring stability data to support retest/expiry dates. Making sure that critical deviations are investigated and resolved. Active participation during audits & visits.
