Officer, QA Validation

Job Description

• Responsible for routine monitoring of Manufacturing Areas.
• 2 Responsible for the routine GMP Inspection & review of Quality Records of other departments.
• 3 To monitor and ensure compliance level of organization is as per current GMP requirement
• 4 Good Documentation recording and updation.
• 5 Responsible for review of URS, DQ and vendor / suppliers documents related to qualification.
• 6 Responsible for preparation of Validation / Qualification protocol and report.
• 7 Responsible for execution and review of qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant Utilities.
• 8 Responsible for adequacy of execution of validations being carried out at prescribed procedures.
• 9 Responsible For Assurance Of Calibrations Before Performing Qualifications.
• 10 Responsible to co-ordinate with cross functional department personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
• 11 Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
• 12 Responsible to check production shop floor compliance.
• 13 Responsible for preparation and review of VMP.
• 14 Responsible for preparation, review, execution data and compilation updation of validation related documents.
• 15 Responsible for handling of failures during qualification by using QMS tools.
• 16 Responsible for Preparation, review and execution of risk assessment activity related to Equipment / Process / Facility / System.
• 17 Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule.
• 18 Responsible for personnel monitoring.
• 19 Responsible to participate in qualification, requalification, area qualification activities.
• 20 Calibration certification review and approval

Qualifications

Qualification - B. Pharmacy