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Head QA/QC & RA for an API Plant

Company:
Reputed API Mfg Co.
Location:
Mahad, Maharashtra, 402301, India
Salary:
Upto 25 lacs per annum
Posted:
November 21, 2016
Description:

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 aspsol.recruitments@gmail.com with details on current ctc, expected ctc and notice period.