Job Description
- Responsible for overall quality oversight functions of contract manufacturing organizations responsible for manufacturing of site transfer products (Sun site & R&D) for Domestic market.
Essential JobFunctions:
- Caused based & frequent visits of the CMO sites for review of process &practices.
- Coordinate with Sun site, commercial, corporate quality audit & the CMO site as SPOC for activities related to product manufacturing and release and other technical issues.
- To review & approve quality agreements between Sun Pharma & CMO site. Also, ensure qualified and approved external service providers are used.
- To participate in new product launch evaluation and technologytransfer.
- To monitor & ensure timely closure of market complaints, quality alerts, recallsetc.
- Review and approval of process validation, analytical validation, hold time study, stability study protocols & reports.
- Tracking of open CAPA s and ensure effectiveness ofCAPA s.
- Review & approval of annual riskassessments.
- To monitor & evaluate productremediation.
- Tracking & implementation of new projects as CMOsites.
- Review and approve SOP s as per Sun Pharma qualitystandards.
- Ensure timely implementation of Pharmacopoieal changes &compliance.
- To ensure timely release of batches in SAPsystem.
Requirements andQualifications:
BasicQualification:
- M.Sc./ B. Pharm / M. Pharm orequivalent.
Industrial Experience &Knowledge:
- Total 22-25 years of experience in Production, Quality Assurance, Quality and compliance in sterile formulations manufacturing.
- Knowledge of GMP s in both domestic and international regulatory environments. In-depth
knowledge of FDA guidance s such as ICH ismust.
- Strong organizational, interpersonal and communicationskills.
- Ability to work effectively in multicultural matrixorganization.
Essential JobFunctions:
- Caused based & frequent visits of the CMO sites for review of process &practices.
- Coordinate with Sun site, commercial, corporate quality audit & the CMO site as SPOC for activities related to product manufacturing and release and other technical issues.
- To review & approve quality agreements between Sun Pharma & CMO site. Also, ensure qualified and approved external service providers are used.
- To participate in new product launch evaluation and technologytransfer.
- To monitor & ensure timely closure of market complaints, quality alerts, recallsetc.
- Review and approval of process validation, analytical validation, hold time study, stability study protocols & reports.
- Tracking of open CAPA s and ensure effectiveness ofCAPA s.
- Review & approval of annual riskassessments.
- To monitor & evaluate productremediation.
- Tracking & implementation of new projects as CMOsites.
- Review and approve SOP s as per Sun Pharma qualitystandards.
- Ensure timely implementation of Pharmacopoieal changes &compliance.
- To ensure timely release of batches in SAPsystem.
Requirements andQualifications:
BasicQualification:
- M.Sc./ B. Pharm / M. Pharm orequivalent.
Industrial Experience &Knowledge:
- Total 22-25 years of experience in Production, Quality Assurance, Quality and compliance in sterile formulations manufacturing.
- Knowledge of GMP s in both domestic and international regulatory environments. In-depth
knowledge of FDA guidance s such as ICH ismust.
- Strong organizational, interpersonal and communicationskills.
- Ability to work effectively in multicultural matrixorganization.
💡 Quick Summary
Seeking a career-building opportunity? The [Apply Now] DGM Corporate Quality position is now open for candidates interested in the Lab Technician / Pharmacist Jobs sector. This role in Mumbai offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Lab Technician / Pharmacist Jobs is a plus.
