Job Summary
The CQ Manager is responsible for Managing the overall CQ Program including planning, coordination and execution of the entire Project Commissioning and Qualification activities in line with Project and Group Procedures.
Managing third party CQ Service provider(s) who is currently responsible for QbD Documentation, FAT Management and Test Documentation Development and Filing.
Main Responsibilities
Main responsibilities and tasks of the incumbent includes but are not limited to:
- Attend Project Leadership meetings
- Set up CQ Organisation including internal weekly meetings
- Input to EPCM tender package and award
- Input to Equipment Vendor and Trade Contractors tender packages w.r.t CQ requirements
- Develop CQ tender package and award
- Development of a Level 4 EPCMCQ Schedule
- Managing CQ Service Provider(s)
- Ensure training is maintain at 90% or above for all CQ employees
- Attend coordination execution meetings, providing an update on issues, risks and ‘showstoppers’
- Input to Engineering deliverables required for CQ
- Input to CM deliverables required for CQ
- Management of QbD Documentation: URS, FCCA and DQ’
- Management of FAT and CQ involvement and expectations
- Support SHE matters in: Implementation of SHE Plan for Start up Phase
- CQ Execution Readiness Oversight: Test Documentation, Materials, Spares and Consumables, Metrology and Calibration, Vendor SAT’s, Automation
- CQ Execution (refer to section below)
- Management of Holiday Planner
Key Performance Indicators
- Strong knowledge and experience of Commissioning and Qualification Phase
- Management: Compliance with schedule at a system and area level with the planned resource levels.
- Feedback from customer (i.e. Quality, HSE, operations)
- Safety: No lost time accident
- Quality: well executed testing with minimum rework and re-execution.
- Quality: all deviations resolved to Client satisfaction and handover completed for all systems.
Ideal Background
- Experience in Process Commissioning and Qualification.
- Languages: English - fluent in speaking and writing.
- Experience: Minimum 10 yrs.
- Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.
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