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.
