- Responsible for maintaining compliance and to ensure GLP in lab
- Responsible for preparation of AMV protocols and reports
- Responsible to provide request to section head for issuance of AWR and to record analysis related activities
- Responsible for execution of Analytical Method Validation/Verification activities in lab
- Responsible to carry out AMV activities as per planning
- Responsible to participate in investigation generated during AMV activities
- Responsible to participate in investigation of OOS/OOT to find out the root cause like verification of force degradation data.
- Responsible for preparation calibration and preventive maintenance planner.
- Responsible for daily temperature monitoring of QC lab area
- Responsible for receipt of Reference Standard, Primary Standard,secondary standards and maintaining the record for the same.
- Responsible for preparation of protocol for Cleaning validation related activities and for execution
- Responsible to maintain documents as per GLP and GMP system
- Responsible to maintain Data Integrity in lab.
Desired Candidate Profile
- Candidate Should be from Pharma - injectable formulation background.
- Should have knowledge of 21 CFR Part 11.