QA Validation

Role & responsibilities

• Engineering daily round and document verification in order to compliance.
• Verification of Calibration planner, preventive maintenance planner to ensure activity done as per scheduled plan.
• GPS clock time verification across the plant as per schedule, Alarm verification of equipment as per planner.
• Audit trail verification of equipment (Drug product & Engineering area).
• Review of memo in system and ensure closure in time with coordination to cross functional team with proper evaluation.
• Preparation / review of Media fill protocol and report.
• Preparation of process / cleaning validation protocol & report.
• Review of cross functional documents (SOP, Validation protocol / report, Study protocol / report etc.)
• Review and evaluation of QMS documents (Change control, Deviation, Incident etc.
• Verification and review of Qualification/ Validation activities.
• Co-ordinate with the cross functional departments as and when required.
• Any other work allocated by Department Head.