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Job Location | Ahmedabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Recruitment Services |
Functional Area | Sales / BD |
EmploymentType | Full-time |
Dear Candidate, We having excellent job opening with leading Pharma industry for the post of Manager- International Business Development , Job Location: Changodar, Dist : Ahmedabad, .Designation: GM - Quality Department- QA- Pharmaceutical Formulation (Small Volume Parenteral, Lyophilised products, Oral Solids, Dry Powder Injections)Education: B.Pharm. B.sc, M.Pharm., M.Sc., Experience: 15 Years Responsibilities:Ensuring compliance to cGMP, GDP for plant operationsReview and compare global quality policies, procedures and directives and regulatory guidelines with site procedures. Identify gaps and ensure inundation of site procedures.Successfully managed Regulated and Semi- regulated market auditsDrive team to productivity and reduce attrition rate; capable of sourcing candidates for own team in minimum timelineTracking and investigations of OOS / OOT from manufacturing site on timely mannerChecking compliance of response given to regulatory observation and queriesReview and approve standard operating procedures, specification, master plans, standard testing procedure, protocols and reportsCoordination with manufacturing, purchase, regulatory and R&D for smooth and timely execution of exhibit and commercial batches and new product launches.Review and completion of change controls of products, process, test method, equipment and facilities.Respond to inspection observation and business affiliate queries. Provide updates to regulatory agencies on compliance to response.Drive internal audit, ensure compliance to schedule and timely CAPA implementation.Approve risk management protocols and reports pertaining to various quality systemsOrganize and lead team to execute timely batch processing through validation and checksManage and respond to market complaints adequately,
Keyskills :
quality customerrelations testcases calibration auditing standardoperatingprocedures continuousimprovementfacilitation internalaudit riskmanagement batchprocessing marketcomplaints egulat yagencies regulato