- The Drug Linker (DL) Commissioning and Qualification (C&Q) Manager reports to the DL Project Manager andfunctionally report to C&Q Program Manager; and is a key member of the Project team.
- The DL C&Q Lead plans, coordinates, and executes C&Q activities for DL process systems, facility utilities, and building services, working closely with Project Technical Managers, Subject Matter Experts (SMEs), Work Package Owners (WPOs), contractors/OEMs, Quality, and Operations.
- The role ensures safe, compliant, and efficient C&Q delivery in accordance with the approved Validation Master Plan (VMP), C&Q Strategy, and Client's standards, achieving readiness for operation and handover per project milestones.
- The role ensures safe, compliant, and efficient C&Q delivery in accordance with the approved Validation MasterPlan (VMP) and C&Q Strategy, aligned to Client's standards and regulatory expectations (GMP/GDP).
- Quality culture and governance
- Strategy and planning
- Validation Master Plan ownership
- Risk-based Commissioning and Qualification
- Construction-to-Commissioning transition
- Permitting and Safety, Health and Environment during start-up
- Documentation and protocol oversight
- Factory and Site Acceptance Testing and Original Equipment Manufacturer coordination
- Live systems stewardship
- Stakeholder engagement
- Schedule control and reporting
- Resource and capability management
- Interface management
- Exception and punchlist closure
- Handover and approvals
- Continuous improvement
- Degree in Engineering, Construction Management, and/or Project Cost Control.
- Experienced in leading risk-based Commissioning and Qualification aligned to a robust Validation Master Plan and System Impact Assessment.
- Full and detailed knowledge of relevant Safety, Health and Environment legislation.
- Strong capability to integrate Commissioning and Qualification schedules with construction and Original Equipment Manufacturer activities.
- Expertise in Factory Acceptance Testing, Site Acceptance Testing, Installation Qualification, Operational Qualification, and Performance Qualification, with strong data integrity and audit readiness.
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Drug Linker Commissioning and Qualification Lead - Singapore - RMA Consultants
Description
Our Client is a Multinational Pharma and Biotech leader constructing a billion-dollar ADC manufacturing facility in Singapore.
ACCOUNTABILITIES
JOB SCOPE
REQUIREMENTS
If you are keen to know more about this role, please email Mary at and send your resume in MS Word format. Note that only shortlisted candidates will be contacted.
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