Head QA / RA for an API Plant (Mahad, Maharashtra)

We are urgently hiring for Head QA/RA for a reputed API Plant located at Mahad. Please find the details below:

Position: Head QA/RA

Department: QA/QC & RA

Location: Mahad, Maharashtra

Reporting Functionally to MD/CEO and Administratively to Head-Operations

Qualification & Experience: M.Sc. with minimum 18 to 20 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

Job responsibilities

  • 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

CTC range: Upto 25 lacs per annum

Industry preference: Pharma / Bulk Drugs / API

Candidates preferred from Chiplun, Roha, Mahad, Patalgana MIDC, Taloja Industrial Area

If the position interests you, please email your resume (CV) at aspsol.recruitments@gmail.com with details on current CTC, expected CTC and notice period.

 

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