Our client is one of the leading names in the specialty chemicals field in India, ever since its inception in 1984. The company has successfully delivered high performance chemicals to a wide range of industry segments in Industrial Chemicals, Pharmaceutical, Bulkdrugs, Agrochemical, Dyestuff, Paints, Polymer, Adhesive industries, Lubricants, Plastics, Rubber, Oil Exploration, and Many more.
Post : Head QA/ QC/ RA (API Plant)
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
Candidate Profile
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:
Job Location: Mahad, Maharashtra
Exp : 18-25 years into API QC/QA Only
Education: M.Sc
Age: 40-48 years
Industry: API
Slary : 25 lacs per annum
Last Date: 15th Feb., 2017
If the position interests you, kindly send across your updated CV (word format) at aspsol.recruitments@gmail.com
a. Current CTC
b. Expected CTC
c. Notice Period
Posted By,
Reema Nambiar,
Aspiring Solutions
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