Quality Control Engineer - Formulation (15-19 yrs)
Job Description
- Responsible to manage analysis of validation batches including exhibit and commercial.
- Responsible for coordination with AR&D for Method transfer activities of new analytical methods.
- Responsible for method transfer to other formulation sites of the organization
- Responsible for investigating OOS / aberrant results and timely closure in accordance with compliance procedures.
- Evaluating and actively involving in responding various queries of RA department for submission batches.
- Responsible for conducting hold time study of products & establishing hold time for in-process samples.
- Reviewing qualification (IQ,OQ,PQ) and calibration documents of analytical instruments.
- Ensuring the traceability and integrity of laboratory data.
- Handling a team of 35 members covering PD Lab, exhibit validation & commercial validation.
- Evaluation of reported laboratory deviations / incidences and providing departmental approval.
- Review of analytical reports and approval of COAs for batch release
- Reviewing process validation, cleaning validation, hold time study protocols & reports.
- Handled independently major regulatory audits such as USFDA, TGA, ANVISA, WHO-GMP, MHRA.
Salary:INR 9,50,000 - 12,00,000 P.A.
Industry:Pharma / Biotech / Clinical Research
Functional Area:Production, Manufacturing, Maintenance
Role Category:Production/Manufacturing/Maintenance
Role:Quality Assurance/Quality Control Manager
Employment Type: Permanent Job, Full Time
This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.
