DGM Quality Assurance for an API Plant (Aurangabad, Maharashtra)

We are urgently hiring for DGM Quality Assurance for a reputed API Plant at Aurangabad, Maharashtra . Please find the details below:

Position: DGM QA (Functionally QA/QC)

Department: QA/QC

Location: Aurangabad, Maharashtra

Reporting to Head-Operations

Qualification & Experience: M.Sc. with minimum 15 to 20 years experience.  Should have faced audits such as USFDA, WHO-GMP, EDQM/COS, KFDA, etc. and  vendor audit, customer audit, etc.

Age: 38-48  years

Job responsibilities

  • To ensure efficient management of RA, QA & QC functions
  • Monitor regulatory environment and ensure that manufacturing practices comply with the regulatory requirements
  • To monitor the Batch release of APIs, Intermediates, raw materials and packaging materials and ensure these are in compliance to SOPs, Specs, Regulatory/customer commitment
  • Encourage quality improvement programs and reduce costs of quality
  • To ensure compliance to GMPs in respective areas as per Quality Policy, Quality System, SOPs
  • 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
  • Review, Approved/Reject change controls related to manufacturing, QC, QA, Engineering as per SOP
  • Conduct self-inspection audits as lead auditor and ensure the compliance to cGMP requirements
  • Review approve/Reject specifications, analytical methods, SOPs, Master Batch Record
  • To handle external audits, review the audit reports, prepare response for audit observations and ensure closure with in time
  • 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
  • Ensuring Deviations, OOS/OOT, audit observations and PQCs are investigated and closed as per SOPS
  • Approving all procedures, specifications, BPRs, laboratory control records before release
  • Should have QA/QC experience

CTC range: Upto 25 lacs per annum

Industry preference: API

Candidates preferred from Maharashtra

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

 

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