CSV Engineer

Skills:

• Preparation execution and Review of Facilities, Utilities, Equipment Commissioning & Qualification documents (including QRM, Change control, URS, DQ, IQ, OQ, PQ, QFR, TM SOPs etc.)
• Preparation execution and Review of computerized system qualification / validation (inclusive of URS, FS, HDDS, VP, IQ, OQ, PQ, VSR, TM etc.)
• Preparation execution and Review of Calibration Criticality Assessment (CAT), Calibration certificates.
• Preparation and Review qualification deviations.
• Preparation execution and Review of Equipment Risk Assessment (Alarm Criticality, Audit Trail Frequency, PM frequency, Overall Equipment RA).
• Review of Technical Data Sheet, Basis of Design (BOD), CQA / CPP Determination sheet, Pre-start Safety Review (PSSR), HAZOP.
• Preparation execution and Review of Area Temperature mapping / temperature distribution studies.
• Support on document preparation and drafting, ensure timely document retrieval from QA as per department requirement.
• Any other job/activity, as assigned by the reporting supervisor / management from time to time.
• Back up support for all GMP manufacturing & GxP activity ensuring all equipment complies with Standard Operating Procedures and Policies.
• Preparation & review of risk Assessment related document activity of engineering department.
• Management of engineering quality management system is in compliant state.
• Support on document preparation and drafting, ensure timely document retrieval from QA as per department requirement.
• Drafting, handling & archival of document related to GAP identified during remediation.
• Document Management.
• To comply with cGMP Practices.
• Ensure Data integrity compliance with respect to laid down procedures and systems.
• Management of calibration planning and timely execution as per calibration scheduler.
• Management and adherence to timely execution and completion of qualification activities within due period.
• Management of qualification planning and management of activity schedule as per planner for equipment s.
• Execution of protocol and review of associated reports to ensure its compliance as per regulatory and site norms.
• HVAC Qualification and Validation.
  

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