Encube Ethicals
Location
Mumbai | India
Job description
Dear Connections!
We are currently hiring for G eneral Manager in Analytical Development Department based at Andheri, Mumbai lcoation. The ideal candidate would be responsible for overall management of department to ensure smooth functioning of Analytical Development Laboratory and Microbiology. Roles and Responsibilities : Monitoring all technical activities of projects which are under development. Reviewing drug master files and to support in API, Excipients vendor qualification process. Review of scope of work and costing proposal of new projects. Review of PIF, IAR and project technical presentations for new projects. Periodic project review including development, Validation, stability, technology transfer activities including criticalities of projects in coordination with managers. Approval of documents involved but not limited to method development reports, analytical reports, method validation reports, specification, test procedure, standard operating procedures, formats of ADL, Equipment/Instrument qualification, MLT Suitability protocols and reports, PET protocols and reports. Review and approval of study protocols of various outsourced studies wherever applicable. Technical support to Goa team wherever applicable and needed. Coordination with project management team for smooth execution of project. Procurement of new instrument / equipment which involve evaluation, negotiation and finalization with proper discussion with higher management. Reviewing and finalizing candidate for various positions in department. Keeping control on QMS / GLP/ compliances of department. Monitoring training / induction schedule of newly joined personals in ADL, IVRT Laboratory, and Microbiology. Reviewing performance goal sheets of immediate reporting persons. Monitoring and ensuring compliances as per USFDA requirement and as per submitted continual improvement plan of R & D. Qualification : M.Sc/M.Pharm/PhD Experience : minimum 20 years in relevant analytical domain Interested candidates can share their updated profile on [email protected]Job tags
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