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: QA Head (API)
Job Description
·To ensure efficient management of RA, QA & QC functions
·Monitor regulatory environment and ensure that manufacturing practices comply with the regulatory requirements
·To monitor the Batch release of APIs, Intermediates, raw materials and packaging materials and ensure these are in compliance to SOPs, Specs, Regulatory/customer commitment
·Encourage quality improvement programs and reduce costs of quality
·To ensure compliance to GMPs in respective areas as per Quality Policy, Quality System, SOPs
·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
·Review, Approved/Reject change controls related to manufacturing, QC, QA, Engineering as per SOP
·Conduct self-inspection audits as lead auditor and ensure the compliance to cGMP requirements
·Review approve/Reject specifications, analytical methods, SOPs, Master Batch Record
·To handle external audits, review the audit reports, prepare response for audit observations and ensure closure with in time
· To review stability study data and establish expiry or retest date
· Implement corrective measures on the basis of quality audits, out of
Candidate Profile
M.Sc. with minimum 15 to 20 years experience. Should have faced audits such as USFDA, WHO-GMP, EDQM/COS, KFDA, etc. and vendor audit, customer audit, etc.
Additional Information:
Job Location: Aurangabad, Maharashtra
Exp : 15-20 years into API QA Only
Education:M.Sc
Industry: API
Slary : 25 lacs per annum
Last Date: 5th 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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