You are hereWork as Sr. Officer QA in Akums Drugs & Pharma
Work as Sr. Officer QA in Akums Drugs & Pharma
AKUMS DRUGS & PHARMACEUTICALS LTD is one of the most innovative, productive and research based pioneer organization of India having its registered office at Delhi and various plants in Haridwar, Uttrakhand giving employment to more than 2000 people. Akums is engaged in the manufacturing of tablets, capsules, injections, syrups on loan licensing and third party manufacturing basis. Akums is having certifications of WHO-GMP, ISO 9001, ISO14001:2004,NDA Uganda, PPB Kenya and complying USFDA , MHRA & other international standards.
Post: Sr.officer QA
1.Reviews or approves all R&D documents (i.e Formula and Procedures, Protocols and Reports, SOPs, R&D formats, Working Instructions, Operating Instructions and relevant forms for the R&D).
2.Supervises quality assurance activities of the R&D and TTD team and ensures compliance with GLP guidelines, other national and international guidelines and SOPs.
3.Reviews the ongoing stability data for support of proposed product shelf life as data becomes available, for submission batches.
4.Ensures that there is a program for approval and monitoring of contract manufacturers and contract facilities for R&D activities
5.Performs internal audits in the R&D as per the audit program and ensures corrective actions and implementation for the same.
6.Acts as QA representative for Technical Transfer between R&D and Production
M Pharm in Quality Assurance or equivalent. GLP, GMP and GCP Auditing experience with intensive training in cGMP. 2 -3 years of experience in QA R&D. Should have experience in R&D pharmaceutical development, critical manufacturing concerns and deviations and justification for reanalysis and redevelopment. Excellent communication and interpersonal skill. Proven ability to work creatively and think analytically. Should be fluent in English (written and oral).
Exp: 2-3 years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, R&D
End Date: 24th June,2012
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