• 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 • Responsible for planning stability studies, writing and/or review of stability protocols, reports, and preparation of technical documents in CTD format • Co-ordinate & follow up stability studies at contract research organisations (CROs)/ Chemical Quality • Control lab of Orion (CQC) • Co-ordinate and follow up validation and method transfer at CROs • Write/check/review analytical and pharmaceutical documents as per regulatory requirements (method and validation documents/ variations/ additional question responses) • Evaluate/ review method validation protocols / reports / analytical methods prepared by CROs. • Reviewing and commenting on change controls, deviations, temperature excursions, stability data, process validation documents and troubleshooting etc. for externally supplied products • Write documents into Orion’s IT systems for example analytical methods • Theoretical evaluation of physio-chemical properties of the drug products and/or raw materials • Co-operation with other departments/ partners • Local in-licensing support • To assist the overall working of Indian Pharmaceutical team • Other possible tasks appointed by Supervisors
