CQ Lead Warehouse and Packaging Lead - Pharmaceutical (Contract – till 31 Dec 28) Up to $15k

Our client is a globally recognised leader in the pharmaceutical and biotechnology industry, with a strong presence in Singapore. The organisation is currently expanding its advanced manufacturing capabilities through a major, high-value facility development, creating exciting opportunities to be part of a large-scale project at the forefront of innovative healthcare manufacturing.

SCOPE OF WORK

• Specific Commissioning and Qualification Execution/Leadership experience for packaging equipment:
  - Automatic packaging line with semi-automatic visual inspection booths and manual inspection booths
  - Packing line including packing, labeling cartooning line and serialization system
• Additional C&Q experience for Warehouse Storage, Freezers, Cold Rooms and Freeze Thaw systems.

RESPONSIBILITIES

As part of the C&Q team reporting to the C&Q Manager, the main responsibilities and tasks are (but not limited to):

• Ensure that CQV activities are executed in accordance with the Commissioning and Qualification Execution Plan and supporting Plans.
• Development of strategies and procedures that support their execution scope.
• Overall planning and execution of the commissioning activities related to allocated areas or systems.
• Leading and coordinating the C&Q execution effort supported by C&Q EPC teams, Engineering, Operations, and external vendors and contractors
• Support development of C&Q schedule for associated scope.
• Coordinating the planning and scheduling of activities with supporting disciplines (HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.)
• Guiding C&Q documentation preparation effort to ensure correctness, completeness and alignment across different areas/systems.
• Lead preparation activities (e.g. start-up, procurement, vendors selection, etc.)
• Coordination and interfacing with vendors for C&Q execution related activities.
• Lead coordination meetings to fine-tune the commissioning preparation and execution with all involved parties
• Reporting of C&Q status, progress and issues during project stakeholders meetings (e.g. Tier 2 meetings, Wall meetings).
• Review and approve CQV test scripts
• Ensure discrepancies encountered are adequately reviewed and approved in accordance with CQEP. Tracking of these deficiencies, including planning and executing the remediation actions
• Support the control of changes, ensuring cost, schedule and compliance are correctly assessed.
• C&Q execution milestones are completed asper baseline schedule
• Ensures C&Q field execution is completed in a safely manner and following Site EHS standards.
• Liaising with EPCM/Vendors on design and construction issues.
• Participate in construction walk-downs and snag list of these systems for Mechanical Completion.
• Ensure that quality standards are followed during C&Q execution. No significant observations in external regulatory inspections for allocated process area.

REQUIREMENTS

• Bachelor's degree in Engineering (Chemical, Mechanical, Process, or related discipline)
• A relevant Third Level or Professional Qualification
• Familiar with methodologies related Risk Based Validation
• Extensive experience in areas/systems under future responsibility. Minimum of 10 years is preferable
• Field CQV execution experience.
• Considerable experience with cGMP
• For Drug Linker: Knowledge of ATEX, process safety, and pharmaceutical engineering standards
  

This is in partnership with the Employment and Employability Institute Pte Ltd (“e2i”).

e2i is the empowering network for workers and employers seeking employment and employability solutions. e2i serves as a bridge between workers and employers, connecting with workers to offer job security through job-matching, career guidance and skills upgrading services, and partnering employers to address their manpower needs through recruitment, training, and job redesign solutions. e2i is a tripartite initiative of the National Trades Union Congress set up to support nation-wide manpower and skills upgrading initiatives. By applying for this role, you consent to RMA Group’s PDPA and e2i’s PDPA.”

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If you are keen to know more about this role, please email Mary at marymarquez@rmagroup.com.sg and send your resume in MS Word format. Note that only shortlisted candidates will be contacted.

Mary Marquez (EA Regn No: R1326974)

RMA Consultants Pte Ltd(EA Licence No: 93C4403)