Bio Scientific Research Laboratories (l) Pvt Ltd. is a vibrant CRO established in the year 2003 and located in the commercial capital of India. Our aim is to provide world-class, technology-driven Clinical and Analytical research services to Pharmaceuticals. BioSRL is bound to proviad T-TRAC Timely - Traceable, Reliable, Affordable, consistent test results.
Post : Quality Assurance - Manager
Qualification : M.SC/B.Pharma/M.Pharma
Experience Required : 10 to 15 Years (CRO experience)
Job Location : Mira Road, Mumbai
Job Description
1. Overall responsibility for ensuring compliance throughout the Organization.
2. Responsible to lead teams (Clinical QA, Bioanalytical QA, Pharma analytical QA, Documentation and compliance teams), guide them in decision-making, develop, plan and execute activities in Quality Assurance and documentation department.
3. Mentor and develop Quality Assurance staff, direct internal staffing and performance management, including hiring, training, coaching and performance reviews.
4. Ensuring that the Quality policy and Quality objectives are established for the Quality Management System and are compatible with the context and strategic direction of the organization.
5. Responsible for leading all departments to be compliant with applicable Regulatory/GCP/GLP/cGMP requirements.
6. Responsible for coordinating, problem solving and monitoring of all aspects of Quality Assurance functions
7. Engaging, directing and supporting teams to contribute to the effectiveness of the Quality management system.
8. Identify areas and topics that need procedures to be set, training to be conducted, and document procedures to be executed in a timely manner.
9. Approve set procedures/SOPs for Quality Assurance and other departments.
10. Review of Quality management systems (Quality manual, Site Master File, Risk Assessment and Mitigation, Business Continuity Policy, Disaster Recovery plan, Deviations, Incidences, Change controls, CAPA, OOS, OOT etc.)
11. Ensure proper Change control and Audit procedures are being followed within the organization.
12. Conduct Induction trainings and Training programs on Data integrity and Good Documentation Practices etc.
13. Performing gap analysis of SOPs and procedures as per applicable GCP/GLP/cGMP guidelines.
14. Performing risk assessment in operations and mitigating the risk with appropriate corrective and preventive actions.
15. Resolving deficiencies of regulatory and sponsor related to Study/product.
16. Prepare and get prepared the documents that may be required to be compliant with applicable Regulatory/ GCP/GLP/cGMP requirements.
17. Approval and authorization of Study Protocol/Reports, Method Validations, Batch test data, forms, CoA’s and other all documents, where relevant Regulatory/GCP/GLP/cGMP requirements become applicable.
18. Preparations, submissions for Regulatory Authorities/Agencies in accordance to current legislation, client requirements and meeting deadlines and responding to their queries appropriately and promptly.
19. Face Sponsor/Regulatory audits with respect to compliance in the organization.
20. Conduct Management review meetings and provide progress report to management.
21. Other duties and responsibilities as delegated by Management.
Interested candidates, kindly share resume in hr@biosrl.com
Last Date : 20th October, 2023
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