Mangalam Drugs & Organics Ltd. - Commenced its business in 1977 of manufacturing of chemicals such as perfumery, organic/inorganic chemicals, disperse dye intermediates, bulk drugs and bulk drugs intermediates at VAPI-Gujarat State. It has a multi-product manufacturing facility and a in-house Research and Development (R&D) Base.
Post: Assistant Manager - Quality Assurance
Job Description:
01. To review all departments Standard Operating Procedures for approval.
02. To review all Specification, Standard Test Procedure and Test Protocols of all Raw Materials, Packing Material, In process, Intermediates and Finished products for approval.
03. To review and approve all qualification documents of Quality Control instruments.
04. To contribute for development of quality system as per corporate guidelines and implement them at the manufacturing location, as per ICH Q7 guidelines.
05. To review SOP of all departments. For updation of the system.
06. To review and approve instruments qualification documents.
07. To review for approval of all procedures impacting the quality of intermediates or API’s as per ICH guidelines and other regulatory authorities.
08. To review Annual product quality (APQR).
09. To carry out internal audit (self inspection) and ensuring compliances on the deviations.
10. To review technology transfer documents and procedures prior to commercialization.
11. To investigate the market complaint.
12. To investigate OOS & approval of the same.
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Desired Profile:
Candidates must have atleast 7 -11 years of experience in API / Bulk Drugs industry. Should have good knowledge of documentation of cGMP guidelines. Candidates should have good leadership skill & excellent communication with fluency in English.
Additional Information:
Experience: 7-11 years
Location: Daman & Diu, Valsad, Vapi
Education: B.Sc-Chemistry, M.Sc-Chemistry
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 10th August, 2011
Forward your resume at, career@mangalamdrugs.com
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