Our client is the world’s second largest Integrated manufacturer of Ephedrine and Pseudo ephedrine salts. Our client's manufacturing facility at Mahad has been audited and approved by the Australian TGA, and the US FDA.
Post: DGM QA (Functionally QA/QC)
Job Description:
* 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
Candidate Profile:
Industry preference: Pharma API Only
Candidates preferred from Maharashtra
Accommodation will not be provided
Additional Information:
Experience: 15-20 years
Education: M.Sc Chemistry
Industry Type: API/ Pharma/ Bulk Drugs
Functional Area: QC/QA
Salary Range: Rs. 25 lacs per annum
Location: Aurangabad, Maharashtra
Last Date: 10th March, 2017
If the position interests you, please email your resume at aspsol.recruitments@gmail.com with details on current ctc, expected ctc and notice period.
Posted by,
Reema Nambiar,
Aspiring-Solutions
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