Development Quality Assurance

Requirement Injectable and Ophthalmic R&D. Department: Development QA. In Complex injectable and ophthalmic drug products for regulated market Total Experience required - 10 to 14 years Qualification: M.Pharm Job Location:- R&D, Rau, Indore, M.P Company: Knovea pharmaceutical, Pvt. Ltd Below is the Job description for the DQA position, To participate and execute the quality management system for R&D centre. To participate & ensure the documents issuance, retrieval, archival and obsoletion of documents. To facilitate quality culture, good documentation practices for R&D related activities. To develop training modules and organize and conduct training sessions for R&D functions. To maintain and execute Quality Management System related to (Change control, Incidents, CAPA, Effectiveness review, Calibration management) Assigning project and document numbering for R&D projects as applicable. Review and approval of protocols/reports for Equipment/instrument Qualification, Stability studies or any product related studies etc. Standard operating procedures (SOP) preparation/review/approval/distribution and archival. Issuance of calibration formats/annexures, SOPs, Specifications/MOA, Equipment/Instrument logbooks and other controlled documents to user. To ensure compliance for calibration/PM & instrument qualification activity in Analytical and Formulation Labs for R&D. To review and approve the technology transfer document and product development report/specification and other technical documents etc. for R&D. To plan and conduct the Internal Audits and act as a facilitator for External Audits for R&D. Ensure compliance for current SOPs, policies, and ICH guidelines and country specific regulatory requirements. Proficient in Microsoft Office (Excel, Word, Outlook & Teams) is an added advantage. Note : AQA/Lab QA experience in Ophthalmics/Injectables can also apply. Interested candidates can DM me and share a CV dipesh.dey@knovea.com,