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:
\xe2\x80\x93 To review documentation of manufacturing and packaging.
\xe2\x80\x93 Prepare and Review of validation protocol like process validation, Cleaning validation, Hold time study protocol, disinfectant validation, BMR, BPR, MFR, MPR etc.
\xe2\x80\x93 Retrieve electronic scans and review batch records based on cGDP, cGMP, CPCs SOPs, and FDA Guidelines.
\xe2\x80\x93 Preparation of Annual Product Review / Product Quality Review reports.
\xe2\x80\x93 Handling of Quality Management System (QMS), Change control, Deviation, Complaints, CAPA, OOS, OOT, SOP Preparation, Document issuance.
\xe2\x80\x93 To Manage Company document system and to ensure its maintenance.
\xe2\x80\x93 To handle all regulatory, FDA and cGMP audits of customer.
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