Website Synergen Bio
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About Synergen Bio
Synergen Bio Private Limited is a DCGI (CDSCO) approved modern Contract Research Organization (CRO) equipped with all the necessary infrastructure to serve the Pharmaceutical and Biotech industry. It was founded by a dedicated group of professionals who share a vision to establish a top-tier Clinical Research Organization renowned for its quality, knowledge, and expertise. Synergen Bio recognizes the critical importance of providing high-quality clinical research services, and our highly experienced team is committed to delivering exceptional services to our sponsors while offering significant cost advantages.
Job Opportunity: Clinical QA Manager (01 Post)
Join Our Team in Pune and Make a Difference in Clinical Research
Qualification Required at Synergen Bio:
MSC, B.Pharm, M.Pharm
Experience Required at Synergen Bio:
6 to 10+ years
Shivajinagar, Wakadewadi, Pune
Tasks and Responsibilities:
- Strategic Quality Assurance: Plan and execute QA activities for Clinical, Pharmacokinetics, and Biostatistics departments.
- Project Management: Manage project timelines and responsibilities, including work distribution, training, project meetings, and coordination with other departments.
- Regulatory Compliance: Review Protocols and CSR for compliance with SOPs, GCP, and applicable regulatory guidelines.
- Audit Execution: Plan and conduct system audits in line with the schedule, prepare audit reports, and ensure compliance.
- Vendor Assessment: Schedule and conduct vendor audits, prepare audit reports, and make recommendations to management regarding vendor/service provider qualifications.
- Training and Development: Train QA auditors and other team members on in-house SOPs and systems.
- Document Review: Conduct retrospective reviews of Clinical Study Documents, including Screening Records, Study CRF, Informed Consent Documents, Medical Reports, and Source Documents.
- Audit Oversight: Review and approve audit plans and reports prepared by the QA auditors for both internal and vendor audits.
- Audit Response: Review responses and CAPA plans for client and regulatory audit reports.
- Compliance Coordination: Coordinate compliance activities for client and regulatory audits.
Immediate joiners are preferred. Interested candidates are encouraged to share their CV at firstname.lastname@example.org.
10th November, 2023
Join Our Team and Be a Part of Quality Clinical Research!
To apply for this job email your details to email@example.com