Roles and Responsibilities
- To undertake responsibilities as Head of Quality assurance Unit.
- Train and guide subordinates in the Quality Assurance Department.
- Maintain copies of all approved study plans and ascertain their compliance with GLP/GMP principles ensuring their availability to all stake holders along with documented proof.
- Maintain copies of all approved SOPs in the facility and availability of the same at relevant locations and persons involved in the process.
- Planning, performing, and maintaining study, facility and process-based inspections in all departments, including test facility management
- Assess the quality of all reports to ensure they are in compliance with GLP/GMP principles, SOP and study reflecting the completeness in all aspects as per the agreed upon procedures and generated raw data.
- Update management, study director, principal investigators about inspection findings, deviations and malfunctionings of both systems and procedures.
- Will ensure availability of QA statement and details of inspections in the GLP reports.
- Ensure that proper and valid Quality Assurance SOPs are available for proper function of department are available.
- To have access to updated Master Study Schedule for planning and conduct of various audit schedules.
- To communicate and co-ordinate with regulatory and other agencies on behalf of the facility as and when required.
- Will ensure proper implementation of inter, intra and external training programs and their documentation.
- To implement any other quality standards as deemed necessary by the management in the test facility.
- Any other works as designated from time to time by management.
Role:Quality Assurance - Other
Salary: Not Disclosed by Recruiter
Industry:Pharmaceutical & Life Sciences
Role Category:Quality Assurance - Other
Employment Type:Full Time, Permanent
PG:MS/M.Sc(Science) in Any Specialization
Bharat Serums and Vaccines
For over five decades, we at BSV have used scientific resources to develop a range of biological, biotech and pharmaceutical products. BSV is a key player in the Reproductive Medicine space and is looking towards team expansion and new product launches as the next steps to make us the no. 1 player in India and abroad.
Contact Company:Bharat Serums and Vaccines
Address:PLOT NO K-27,,ADDITIONAL MIDC,ANAND NAGAR,AMBERNAT H EAST , NAVI MUMBAI, Maharashtra, India