• Writing of Product Quality Review (PQRs) for own production products & ensure its timely approval. • Preparation and review of other documents related to PQRs. • Requesting, follow-up and tracking of PQR related data. • Review of externally supplied PQRs, related coordination and follow up with vendor and other stakeholders. • Reviewing and commenting on change controls, deviations, temperature excursions, stability data, process validation documents, troubleshooting etc. for ESO products. • To evaluate dossiers and suggest the additional requirements (if any) for probable new market. • Responsible for planning stability studies, writing and/or review of stability protocols, reports and preparation of technical documents in CTD format. • Co-ordinate and follow up stability studies at CROs/CQC • Writing and/or reviewing of process validation, technology transfer, study batch documentation for own products • Write/check/review pharmaceutical documents as per regulatory requirements. • Write documents into Orion’s IT systems. • Preparation and maintenance of lists/documents/records and archiving at appropriate place. • Co-ordination with other departments / partners • Achievements of responsibilities within the agreed timelines • To assist the overall working of Indian Pharmaceutical team • Other tasks appointed by Supervisors
