Job Description

Responsible for execution and review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility / Process and Plant utilities. Responsible to co-ordinate with manufacturing personnel for respective Qualification / Validation / Requalification activity for timely completion of activities. Responsible for preparation and review of Process Validation protocol and compilation of process validation report. Responsible for preparation and review of Cleaning Validation protocol and compilation of cleaning validation report. Responsible for preparation and review of Packaging Validation protocol and compilation of Packaging Validation report. Responsible to co-ordinate with Quality control and Micro department for sample preparation and testing of Validation / Equipment, Utilities and System qualification / Re-qualification study. Responsible to conduct sampling activity as per the approved cleaning validation protocol. Responsible for preparation, review and execution of risk assessment activity related to Equipment / Process / Facility / System. Responsible for preparation and follow up for collection of data related to Validation Master Plan schedule. Responsible for preparation / Revision of validation SOP's pertaining to QA validation department. Responsible to review of Calibration certificates and reports. Responsible for review of SOP's pertaining to other department. Responsible for preparation and review of investigation report for NOI. Responsible for carry out Impact assessment for any maintenance activity in equipment/system/area. Responsible to review of change control and deviation to evaluate validation requirement.

Skills

: Regulatory Knowledge, Validation Methodologies, Risk Management, Communication & Problem-Solving & Decision-Making



B Pharm / M Pharm