Skills:
Equipment Qualification, Calibration, Equipment Risk Assessment, Area Temprature, HVAC Validation, HVAC Qualification,

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 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.

How to Apply

Interested Candidates Can Email Their Resume To

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For More Details, Contact Us At

9109102346