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 : Clinical QA - Manager (01 post)
Qualification : MSC, B.Pharm, M.Pharm
Experience : 06 to 10+ year's
Job Location : Shivajinagar, Wakadewadi Pune.
Tasks Responsibilities :
• Responsible for plaining and executing the QA activities for Clinical. Pharmacokinetics and Biostatistics departments.
• Handling Project timelines and responsibilities for work distribution, training, meeting project and coordinating with other departments.
• Review Protocol and CSR compliance to SOP, GCP and applicable regulatory guidance's.
• Plan and conduct system audit of various section of as per the schedule, prepare audit report and ensure compliance for the same.
• Plan and conduct vendor audit of various vendor/ service provider as per schedule and prepare audit report and recommend to management whether vendor/ service provider qualified or not.
• Train QA auditors and others on in house SOP’s / system.
• Retrospective review of Clinical Study Documents like Screening Records, Study CRF, Informed Consent Document, Medical Reports and Source Documents etc.
• Review and approval of audit plans and audit reports prepared by the team of QA auditors for internal and vendor audit
• Review response and CAPA plan for client audit report and regulatory audit report
• Coordinates the compliance activities for client audit and regulatory audit
Note : Immediate joiner preferred
Interested Candidate Share CV on careers@synergenbio.com
Last date : 10th November, 2023
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