Head ( Senior Manager / Chief Manager ( AGM ) - QA / QC & RA

GenNext Human Resource Management
  • Raigad
  • 20-30 lakh
  • 18-28 years
  • Views
  • 14 Dec 2016

  • Compliance/ Regulatory

  • 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 faced regulatory audits such as USFDA, WHO-GMP, EDQM/COS, KFDA, etc. and vendor audit, customer audit, etc.

#Position: Head (Senior Manager/ Chief Manager(AGM) QA/QC & RA

#Good Communication, Interpersonal Skills & Presentable

#Qualification & Experience : MSC. 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.

# Job Location : Mahad, (Raigad District Maharashtra)


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