Requirement Injectable and Ophthalmic R&D.
Department: Development QA.
In Complex injectable and ophthalmic drug products for regulated market
Total Experience required - 2 to 5 years
Qualification: M.Pharm
Job Location:- R&D, Pigdamber, Rau, Indore, M.P
Company: Knovea pharmaceutical, Pvt. Ltd, R&D.
JOB DESCRIPTION FOR DQA:
- To participate and execute the quality management system for R&D setup.
- To participate & ensure the documents issuance, retrieval, archival and obsoletion.
- 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 management, 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, SOP’s, 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 SOP’s, policies, and ICH guidelines and country specific regulatory requirements.
Proficient in Microsoft Office (Excel, Word, Outlook & Teams) is an added advantage.
Candidates having experience in Analytical R&D/AMV for Injectable and Ophthalmics formulations can also apply.
Only relevant and interested candidates can share their profiles at
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