Quality Assurance/Quality Control Manager

Sarthee Consultancy
  • Raigad
  • 15-25 lakh
  • 18-25 years
  • Views
  • 05 Jan 2017

  • Production/ Manufacturing/ Engineering

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

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
Should have Regulatory Affairs experience
Should have faced regulatory audits such as USFDA, WHO-GMP, EDQM/COS, KFDA, etc. and vendor audit, customer audit, etc.


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Sarthee Consultancy