We have an urgent opening with our well reputed API Mfg Co. for their plant at Mahad. Please find the details below:
Position: Head QA/QC & RA
Location: Mahad (accommodation can be considered as per availability)
Reporting to Functionally to MD/CEO and Administratively to Head-Operations
Qualification & Experience: M.Sc. with minimum 18 to 25 years experience. Should have faced regulatory audits such as USFDA, WHO-GMP, EDQM/COS, KFDA, etc. and vendor audit, customer audit, etc.
Age: 40-48 years
• To ensure efficient and effective management of Regulatory Affairs, QA & QC functions
• Monitor regulatory environment and ensure that manufacturing practices comply with the regulatory requirements
• Ensure strict compliance to cGMP/GLP guidelines in all areas of QC lab
• Prepare documentation packages for submission to various overseas regulatory agencies
• Evaluate levels of in-house regulatory compliance and prepare answers to queries from regulatory authorities
• Encourage quality improvement programs and reduce costs of quality
• Define goals for validation and decide on the scope of all validation exercises related to products, processes and facilities
• Ensure timely approval of material by quality control and also to enable timely dispatch of finished products in accordance with statutory rules and regulations and customer requirement
• Provide guidance to Training Managers and approve all cGMP/GLP training programs for technical functions
• To review and approve all cGMP related documents
• Conduct self-inspection audits as lead auditor and ensure the compliance to cGMP requirements
• To approve or reject all finished products
• To conduct vendor audits & approval of new vendors
• To review stability study data and establish expiry or retest date
• Implement corrective measures on the basis of quality audits, out of specification, deviation data and market complaint analysis
• To review and approve of documents with respect to change controls, market complaints, deviations, OOS, reprocess, OOT, returns and annual product quality review
• Approving all procedures, specifications, BPRs, laboratory control records before release
CTC range: Upto 25 lacs per annum
Industry preference: Bulk Drugs / API
Candidates preferred from these locations: Patalganga MIDC, Mahad, Roha, Chiplun, Taloja industrial area
If the position interests you, please email your resume at email@example.com with details on current ctc, expected ctc and notice period.
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