Synergen Bio Private Limited is a DCGI(CDSCO) approved new age CRO with all necessary infrastructure to cater to the Pharmaceutical and Biotech industry, established by a group of enthusiastic professionalswith a vision to set-up a premium Clinical Research Organization known for its Quality, Knowledge and Expertise. Synergen Bio understands the importance of quality clinical research services and our significantly experienced team strives to provide the same to our sponsors at significant cost advantages.
Post : Senior Manager (QA)
Department : Quality Assurance (QA)
No Vacancy : 01
Job Description
• (Plan and conduct system audit of various section of Bio-analytical department. General Admin, and Biostatistics department as per the schedule, prepare audit report and ensure compliance for the same.
• Ensuring compliance of system as per SOP, protocol and local regulatory guideline
• Review of SOPs, Protocols and reports.
• Planning and overseeing the conduct of in-process, retrospective audit in clinical, bio- analytical research department and system audit in Project management and Bio¬pharmaceutics, general administration and IT department.
• Ensuring that all studies are conducted in adherence with protocol, SOP’s, GC'P. GLP and other applicable regulatory guideline.
• Review of response and CAPA plan for client audit report and regulatory audit report
• Handling Project timelines and responsibilities for work distribution, training, meeting project and Method Validation timelines, coordinating with other departments.
• Review of validation and calibration data of the instrument/equipment of all departments for compliance.
• Review of CSV documents.
• Suggesting modification in the current process to improve quality and to minimize the errors.
Qualification : Msc, B. Pliarm, M. Pharm
Experience : 15+ years
Note : Immediate joiner preferred
Job Location : Shivajinagar, Wakadewadi Pune.
Last Date : 30th December, 2023
Interested Candidate Share CV on careers@synergenbio.com
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