Job Description

Key Responsibilities:

• 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.

Qualification: M.Sc / B.Pharm / M.Pharm
Experience: 8-12 years

Executor Level- Validation for Injectables plant with experience of working in regulated industry including US and/or Europe markets..