Job for Head QA/QC & RA at Aspiring Solutions

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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