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Job Location | Ahmedabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Recruitment Services |
Functional Area | Sales / BD |
EmploymentType | Full-time |
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 updation 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 adequatelyPerform Risk analysis and management at regular intervalsHave proven multi department and multi- tasking operation Keyskills : Company Profile emerging Pharmaceutical company with manufacturing unit approved by 14 overseas countries. Promoting over 250 registered brands in 58 countries, It operates through 72 channel partners leveraging the marketing activities overseas. Recruiter is interested to get potential application for this job opening.Recruiter will proceed your potential application and will be in touch with you shortly.,
Keyskills :
standardoperatingprocedures continuousimprovementfacilitation riskanalysis internalaudit riskmanagement batchprocessing channelpartners marketcomplaints egulat yagencies regulat yguidelines professionall