Development Quality Assurance Knovea Pharmaceuticals Pvt.Ltd.
Knovea Pharmaceuticals Pvt.Ltd.
Office Location
Full Time
Experience: 10 - 10 years required
Pay:
Salary Information not included
Type: Full Time
Location: Indore
Skills: Quality Management System, Training, change control, CAPA, SOP Preparation, Compliance, Microsoft Office, Good Documentation Practices, Calibration Management, Internal Audits, external audits
About Knovea Pharmaceuticals Pvt.Ltd.
Job Description
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,