Skills:
Equipment Qualification, Validation, QMS, Quality Assurance, Basis of Design, Cleaning Validation,
Hiring Alert
Instrumentation and Control Solutions is hiring for
Industry : Pharma Industry
Location: Goa
Notice Period : Immediate to 30days
Profile - Engineering QA
Experience - 6-10 years
Key Skills & Responsibilities
The OHC-4 project involves extensive qualification and validation tasks across a wide range of facilities, equipment, utilities, and systems. The QA responsibilities include:
- Review of Facilities, Utilities, Equipment Commissioning & Qualification documents (including QRM, Change control, URS, DQ, IQ, OQ, PQ, QFR, TM SOPs etc.)
- Review of computerized system qualification / validation (inclusive of URS, FS, HDDS, VP, IQ, OQ, PQ, VSR, TM etc.)
- Review of Calibration Criticality Assessment (CAT), Calibration certificates.
- Preparation/Review of SOPs (as applicable).
- Review of deviations, qualification deviations.
- Review of change control, CAPA associated with the Facilities, Utilities, Equipment, Computerized System.
- Review of facility layouts, Isometric Drawings, P&I Diagram, Architectural and structural Drawings of facility, Electrical Drawings.
- Review of Cleaning Validation Documents (surface area, worst case location determinations).
- Review of System Impact Assessment (SIA), 21CFR Assessment Checklist, Automated system Impact Assessment, Equipment Equivalency.
- 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.
- Review of Area Temperature mapping / temperature distribution studies.
This scope demands specialized QA personnel with minimum 7 - 10 years of experience in pharmaceutical manufacturing and engineering qualifications and should have exposure for qualification of new facility, new Equipments (like, Bin Blender, Isolator, De-duster cum Metal detector, Mist Shower, Co-Mill, Weighing Balance, HSMG, FBE, BMS, Compression Machine, Nitrogen gas generator, Water System, Milling equipment), new Utilities (HVAC, Compressed air, Purified Water, Potable Water, Nitrogen gas).
- VOLUME OF EQUIPMENT AND SYSTEMS TO BE QUALIFIED:
The Document Lists Approximately 116 Individual Qualifications Across
Major equipment (e.g. Bin Blenders, Compression Machines, Granulation units)
Minor equipment (e.g. Mist Showers, Pumps, Lifts)
Utilities (e.g. HVAC with BMS, Water Systems, Nitrogen Gas)
Facility Qualifications (25 Areas)
This volume is substantial and cannot be managed by the existing QA team without compromising timelines or quality.
- ANTICIPATED DURATION AND TIMELINE
The anticipated duration for OHC-4 project qualification activities is from December 2025 to June 2026 (approx. 7 months). This is a time-bound project requiring dedicated resources to ensure timely execution without impacting ongoing operations.
- RECOMONDED QUALIFICATION REQUIREMENT:
- B. Pharm / M. Pharm / B. Sc / M. Sc / B.E.
- Min. 7 to 10 years experience in pharmaceutical industry in handling pharmaceutical manufacturing as well as engineering Facilities, Utilities, Equipment, computerized system qualification / validation and Quality Management System from engineering / Production / Quality Assurance.
- Should have exposure for qualification of new facility, new Equipments (like, Bin Blender, Isolator, De-duster cum Metal detector, Mist Shower, Co-Mill, Weighing Balance, HSMG, FBE, BMS, Compression Machine, Nitrogen gas generator, Water System, Milling equipment), new Utilities (HVAC, Compressed air, Purified Water, Potable Water, Nitrogen gas).
