Deputy Manager/Manager/Senior Manager- CQA

1 month ago


hyderabad, India Eugia Pharma Specialities Ltd Full time

Designation

Manager/Senior Manager


Department

Corporate Quality Assurance


Qualification

M.Sc. /B. Pharmacy/M. Pharmacy


Experience

12-20 Years


Primarily Responsible For

  • Subject Matter expert in sterile manufacturing activities.
  • Conduct audits and review the practices/procedures of manufacturing process in sterile injectable sites.
  • Review of Batch manufacturing records and Media fill (Aseptic process simulation) records.
  • Review of aseptic practices, behaviours, CCTV footage in clean rooms.
  • Review of smoke studies/ Air flow visualization studies.
  • Conduct gap assessment against the regulatory requirements/observations.
  • Review/approval of QMS elements such as Change Controls, Deviation / Exceptions / PNCs/OOS/OOL etc in respective software.
  • Impart trainings on Procedures, Policies, and regulatory guidance documents.
  • Preparation, review/approval of Standard Operating Procedures and Policies.



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