Manufacture general injectables, cephalosporins, hormones, carbapenems and liquid ophthalmics. It is one of the largest manufacturers of small volume sterile parenterals and antibacterial parenteral s finished products in India.
Post: Manager Quality Assurance (Documentation)
To make documents as per requirement and carry out Inspection at factory, To train manpower, Maintaining documents as per FDA requirement.
- Preparation of documentation & maintaining sample, records, laboratory as per F.D.A. regulation. Such as implementing good housekeeping training of manpower methods of cleaning machines, raw material, finished goods, packing material, storage, making plans for all the operations maintaining complete records etc.
- Handling of QMS, by review of Change control, Deviations, CAPA, OOS management
- Implementing all the formalities as per Schedule M required as per FDA and making SOP, instruction and further making changes in the system by training workers, supervisors etc.
- Allocation of work & supervising the work of a team of skilled and experienced chemist.
- To ensure strict adherence to G.M.P. and S.O.P. guidelines.
- Responsible for preparation & updating of documents as per G.M.P. and G.L.P.
- Implementation of ISO 9002 & ISO 14000 system, OSHAS 18000 and other good manufacturing standard.
To review and implementation of various SMF, Quality Manual, SOPS, Specifications and Records
Experience: 10- 15 yrs.
Education: M. Sc. / B. Pharma/M.Pharma
Qualification: M. Sc, B. Pharma, M.Pharma
Location: Sirmour Dist, Himachal Pradesh
Industry Type: Pharma / Biotech / Clinical Research
Functional Area: QA
Last Date: 18th Feb, 2013
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