We Have Urgent Requirement Assistant Manager Quality Assurance (QA) for leading Pharmaceutical company at Santej Ahmedabad. Experience: Minimum Experience of 5 To 7 years in Quality assurance and regulatory.
Industries: Pharmaceutical company
Qualification: B.Pharm / M.Pharm Only Roles and Responsibilities:
- To review documentation of manufacturing and packaging.
- Prepare and Review of validation protocol like process validation, Cleaning validation, Hold time study protocol, disinfectant validation, BMR, BPR, MFR, MPR etc.
- Retrieve electronic scans and review batch records based on cGDP, cGMP, CPCs SOPs, and FDA Guidelines.
- Preparation of Annual Product Review / Product Quality Review reports.
- Handling of Quality Management System (QMS), Change control, Deviation, Complaints, CAPA, OOS, OOT, SOP Preparation, Document issuance.
- To Manage Company document system and to ensure its maintenance.
- To handle all regulatory, FDA and cGMP audits of customer.
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