Sr. Officer / Officer - QC ( AMV Profile)

• 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.