Review & update of Site Validation Master Plan & Related Annexes.
Follow up Execution of all validation / Qualification activities:
- Facilities Qualification
- Equipment / Systems / Utilities Qualification (URS/FAT/SAT/DQ/IQ/OQ/PQ)
- Manufacturing process validation
- Holding Time studies (Bulk and cleaning).
- Cleaning Method validation
- Computer system validation
- Transport validation
- Building Qualification
Follow up Execution of Calibration program and execution of calibration plans including execution of thermal mapping studies
Review of validation / Qualification reports & Related Annexes.
Review for all standard operating procedures related to the validation activities.
Ensures that all activities are done according to Approved Validation Master Plan, relevant Who, cGMP and ISO standards.
Bachelor's degree in Pharmaceutical Science, Science or Engineering3 - 5 years of experience in Validation/Production and/or Operational QualityKnowledge of measurements process and validation readinessGood Command of English languageAnalytical SkillsProblem-Solving Communication