- Responsible for review of URS, DQ and vendor/ supplier’s documents related to qualification.
- Responsible for preparation and review of Validation/ Qualification protocol and report.
- Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities.
- Responsible to co-ordinate with manufacturing, Engineering and QC personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
- Responsible for preparation and review of media fill and hold time protocol and report.
- Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
- Responsible for assessment of Change Control, Deviation, CAPA, Investigation etc.
- Responsible to prepare protocols of process validation and cleaning verification/validation.
- Responsible to conduct sampling activity as per the protocols (Process validation and clearing validation etc.).
- Responsible for preparation, review and execution of risk assessment activity related to equipment/ process/ facility/ system.
- Responsible for preparation and updation of Annual Validation Planner.
- Responsible for review of the master and executed documents of cross functional team (CFT).
- Responsible for review of master batch documents.
- Responsible to review the different type planner and calibration certificates.
- Responsible to monitor cGMP compliance at shop floor.
- Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HOD’s instruction and guidance.
Qualifications
Executor Level- Validation for Injectables plant with experience of working in regulated industry including US and/or Europe markets.