C&Q Compliance Support - 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

• Provide additional support to the C&Q Manager and Compliance Lead to drive and align on topics related and/or supporting project C&Q Program.
• Develop more detail implementation plans/strategies in accordance with the framework provided in C&Q Plan, Global Guidelines/SOPs.
• Liaise with stakeholders to get an alignment on plans/strategies proposed. This will include (but not limited to) EPCM, Third party suppliers, End User and QA.
• Ad-hoc supporter for other C&Q Leads for specific topics related to their scope.
• Support digital platforms scope for the project.

RESPONSIBILITIES

As part of the C&Q team reporting to the Compliance Lead, 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.
• Support C&Q schedule activities.
• Guiding C&Q documentation preparation effort to ensure correctness, completeness and alignment across different areas/systems in accordance with strategies agreed.
• Lead meetings to fine-tune commissioning topics.
• Support the control of changes.
• 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
• Digital exe .e.Kneat, Veeva, Val genesis, etc.)
• Experience with cGMP

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 [email protected] 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)