QA/QMS and optional IPQA Officer - Renown Pharmaceuticals Pvt. Ltd. - Padra, Vadodara, Gujarat - 391445
(2024-11-19)
- To perform total IPQA related activity in warehouse, manufacturing and packing on shop floor.
- Responsible to provide the line clearance before proceeding wherever required.
- To carry out the sampling of semi-finished, challenges Samples, hold time study Samples of validation / exhibit batches as per defined frequency and methodology of protocol during batch manufacturing & samples to be forward to QC.
- Review of executed BMR, BPR and relevant document before QA release of product and regulatory submission.
- To maintain control samples & records for collection, storage & destruction.
- To prepare and review Annual Product Quality Report.
- Review of documents of respective areas and logbooks for adequacy and completeness.
- Preparation, Execution, Compilation & timely review Validation Protocol, Reports and Hold Time Study Protocol for regulatory submission.
- To co-ordinate with all cross functional team & other support functions for completing validation and qualification activity.
- To carry out sampling during Process Validation as per protocol and compilation of Validation Reports.
- Issuance and retrieval of MFC, BMR and BPR, formats and logbooks of all department as per requirement.
- To ensure the online documentation followed at site.
- To prepare and review the standard operating procedure for quality assurance department and other department.
- To participate / support in regulatory, customer audit and its compliance.
- To maintain self-training record.
- To handle the QMS activities.
- To ensure the good housekeeping procedure followed at site.
- To ensure the safety related aspects during activity.
- Any job activity assigned by HOD.
