Name Of the Company Zydus Life Sciences
Industry Pharmaceuticals
Website of the company - https://www.zyduslife.com/zyduslife/
Location Zydus Life Science
Position - Assistant Manager / Deputy Manager
No. Of Working Day in Week : 6 Days
Experience Required Between 8-13 Years Of Experience
Vacancy details:
- Department : EMO Quality (Region : Gujarat- Ahmedabad)
- Qualification: MSc, B Pharm, M Pharm
- Designation Assistant Manager/ Deputy Manager
Experience required : Less than 11 Years (IPQA/QA-Micro)
- Large volume parenteral, sterile Finish Product
- OSD validation, audit & compliance
- QA & QC Document review and Audit and compliance.
- Microbiology documents review and audit competency.
JD for new candidate:
- BMR/BPR/ Analytical data review. To monitored Batch manufacturing & IPQA activity for batch release.
- To able to perform investigation (OOS & Complaint) independently, Effective CAPA verification and quality oversight activity.
- Ensure Good manufacturing practices and compliances as per schedule M requirement at contract manufacturing site.
- Conduct site GMP audit effectively, prepare Audit report, ensure compliance timely manner. Verify the compliance to the audit observation and CAPA execution and effectiveness of CAPA.
- Escalate repetitive complaints/non-compliance issues at contract manufacturing site.
- To Conduct joint analysis of p2p products. Quality control documents review.
- Review OOS, batch failure, investigations and ensure it's closure before batch release for distribution.
- Review technology transfer documents, batch records, and analytical data during the site visit.
- Support trouble shooting during site transfer, Analytical method transfer and routine product manufacturing. Share the issue of repetitive nature.
- Ensure stability study sample are charged.
- To discuss for trouble shooting with Manager as required.
- Microbiology documents review and audit competency.
