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

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



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