Work as Head-QA/QC & RA (API) at API Mfg Co, Mahad

Our client is a well known name into API/ Bulk Drug Sector

Post: Head-QA/QC & RA (API)

No. of Posts: 01

Job Description:
· 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 Reporting to Functionally to MD/CEO and Administratively to Head-Operations

Candidate Profile:
- Industry preference: Bulk Drugs / API
- Candidates preferred from these locations: Patalganga MIDC, Mahad, Roha, Chiplun, Taloja industrial area
- 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.

Additional Information:
Education: M.Sc
Experience: 18-25 years
Location: Mahad, Maharashtra
Job Type: QA/QC Management
Industry: API/ Pharma/ Bulk Drugs
Salary: 25 lacs per annum
Last Date: 1st August, 2016