- Collection of data of products under PQR studies from batch records, analysis certificates, stability studies & validation reports to be handled in product quality review.
- Trending analysis of data raised from each PQR & review of control charts
- Tracking of all approved CAPAs and communicating them to all concerned parties
- Follow-up of CAPA plans implementation and effectiveness
- Track all deviations and management of deviations, participate in investigation & follow-up of CAPA.
- Handling and reporting change control requests to be evaluated by the compliance section head
- Creation and update of a plan for quality risk management
- Management of risk assessment, Participate in QRM team & Follow up on recommendation actions
- Review vendor qualifications and conduct the Supplier evaluation
Bachelor’s degree in Pharmacy or Science is required.Experience from 3-5 years in Quality Assurance Compliance role is a must.Pharmaceutical industry experience is a must.6th October city residents are preferred and nearby areas.Area of expertise : PQR Product Quality Review ,Customer complaint, Risk Assessment , OOS,Change Control, Vendor qualifications ,Quality Agreement