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Head QA/QC & RA for an API Plant

Reputed API Mfg Co.
Mahad, Maharashtra, 402301, India
Upto 25 lacs per annum
November 21, 2016

We have an urgent opening with our well reputed API Mfg Co. for their plant at Mahad. Please find the details below:

Position: Head QA/QC & RA

Location: Mahad (accommodation can be considered as per availability)

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

Qualification & Experience: M.Sc. 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.

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

CTC range: Upto 25 lacs per annum

Industry preference: Bulk Drugs / API

Candidates preferred from these locations: Patalganga MIDC, Mahad, Roha, Chiplun, Taloja industrial area

If the position interests you, please email your resume at with details on current ctc, expected ctc and notice period.