Title:  Manager

To maintain and ensure cGMP/cGLP in the Quality Control Department.

To maintain documents as per GLP requirements.

Planning and management of Analytical Method Transfer (AMT), PV samples and FP samples.

Review of AMT/PV sample analytical reports and all related documents.

Formal investigation of analytical errors, out of specifications, OOT test results and documentation of investigation, including action taken.

To follow safety procedure in the laboratory.

To verify the result of analysis carried out by contract laboratory.

Ensuring training of analyst in laboratory techniques, quality control procedure and principles of cGLP/ general analytical methods /instrumentation.

Monitoring implementation of changes as per change control.

Handling of LIMS software, LMS, Lab solution, Track wise, EWS and Empower software etc.

Secondary responsibility:

Review and approval of system related documents such as protocols, report, agreements, Specification and ATP.

Any other additional work allocated by reporting authority.