Website Synergen Bio Private Limited
About Synergen Bio Private Limited
Synergen Bio Private Limited is a DCGI (CDSCO) approved Contract Research Organization (CRO) equipped with the essential infrastructure to serve the Pharmaceutical and Biotech industry. The organization was established by a group of enthusiastic professionals who share a vision of creating a top-tier Clinical Research Organization known for its commitment to Quality, Knowledge, and Expertise.
Synergen Bio recognizes the critical role that quality clinical research services play in the pharmaceutical and biotech sectors. The team, which boasts significant experience, is dedicated to delivering high-quality services to sponsors, while also providing them with cost advantages.
Job Post: Senior Manager (QA)
Department:
Quality Assurance (QA)
Vacancy: 01
Job Description:
Plan and conduct system audits across Bio-analytical, General Admin, and Biostatistics departments. Prepare audit reports and ensure compliance.
Ensure system compliance with SOPs, protocols, and local regulatory guidelines.
Review SOPs, Protocols, and reports.
Oversee in-process and retrospective audits in clinical, bio-analytical research, and system audits in Project Management, Bio-pharmaceutics, general administration, and IT departments.
Ensure studies adhere to protocols, SOPs, GCP, GLP, and other regulatory guidelines.
Review responses and CAPA plans for client and regulatory audit reports.
Manage project timelines, work distribution, training, and coordinate with other departments.
Review validation and calibration data of instruments/equipment for compliance.
Review CSV documents.
Propose process modifications to improve quality and minimize errors.
Qualification:
MSc, B.Pharm, M.Pharm
Experience:
15+ years
Note:
Immediate joiner preferred
Job Location:
Shivajinagar, Wakadewadi Pune.
Last Date:
30th December 2023
Interested candidates, please share your CV at careers@synergenbio.com.
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