CSV Engineer

Instrumentation and Control Solutions is hiring for CSV Engineer.

Industry : Pharma Industry

Location: Goa

Notice Period : Immediate to 30days

Profile - Engineering CSV (Qualification)

Experience - 5-7 years

• 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 duringremediation.
• 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.

How to Apply

Interested candidates can email their resume to:

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