Website Zydus Group Ltd
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
