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.

Qualifications

Qualification: M.Sc / B.Pharm / M.Pharm

Experience: 2-5 years

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

Executive, QA Validation