Akums Drugs & Pharmaceuticals Limited; Haridwar, Uttaranchal (India) was established & formed in the year 2004 by Shri D. C. Jain, Shri Sanjeev Jain & Shri Sandeep Jain, the Promoter Directors, having over 30 years of experience in Pharmaceutical Manufacturing.
Post: Quality Assurance Manager
Job Description:
• Candidate should have experience of injectables including basics of QC and production activities.
• Ability to handle change controls, deviations, OOS, market complaints and failure investigations etc.
• Review approval of master validation program including equipment, processes and facilities.
• Well conversant with the quality management systems & documentation control.
• Qualification/Validation of water, cleaning and analytical method, equipments, process and Media fill validation as per the current regulatory requirement.
• Responsible to ensure proper investigation of market complains, vendor audits, annual product review and process capability.
• Implementation of cGMP and well conversant with the concepts of international norms, Candidate having exposure of international audits (ANVISA,UK-MHRA and US-FDA)) will be preferred.
• Good communication with strong leadership skill, planning and excellent problem solving skills are essential.
Candidate Profile:
M.Sc/B.Pharm/M.Pharm with 4-6 years experience in validation, documentation, exposure of international regulatory audits. At least 2 years of experience on similar position will be preferred.
Additional Information:
Experience: 4-6 Years
Location: Haridwar
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 16th Nov., 2011
Forward Your Resume at, resume@akums.in
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