C&Q Compliance Support

Advanced Manufacturing Tech Solutions PTE. LTD. (AMTSOL); Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

AMTSOL is seeking an experienced CQV Lead to drive commissioning and qualification activities for Life Science manufacturing technology projects in Singapore. You will support the C&Q Manager and Compliance Lead, developing implementation plans and aligning with global guidelines.

You will liaise with EPCM, third-party suppliers, End Users and QA, while guiding CQV documentation, schedules and change controls to ensure regulatory-compliant execution.

Qualifications

• Experience leading C&Q activities in life sciences projects.
• Strong ability to coordinate with multiple stakeholders and teams.
• Familiarity with CQV execution plans and regulatory alignment.

Responsibilities

• Provide support to the C&Q Manager and Compliance Lead on CQV topics.
• Develop detailed implementation plans aligned with global guidelines.
• Liaise with EPCM, third-party suppliers, End Users and QA for alignment.
• Ad-hoc support for other C&Q leads within scope.
• Support digital platforms scope for the project.
• Ensure CQV activities execute per the Commissioning and Qualification plans.
• Develop strategies and procedures to support execution scope.
• Support CQV schedule activities and documentation alignment.
• Lead meetings to refine commissioning topics and manage changes.
• Maintain quality standards during CQV with no significant regulatory observations.

Education

PMP (Project Management Professional) or equivalent

Bachelor's degree in Engineering

Previous team handling experience

Tools

Kneat

Veeva

Valgenesis

Job description

AMTSOL:

A Leader in Life science Manufacturing Technology solutions, we are looking for top talent to be part of the dynamic team and drive the growth of the business.

Roles Scope:

• 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 support for other C&Q Leads for specific topics related to their scope.


• Support digital platforms scope for the project.

• 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.

Education & Certifications:

• PMP (Project Management Professional) or equivalent certification


• Bachelor's degree in Engineering (Chemical, Mechanical, Process, or related discipline)


• Digital execution platforms experience (i.e. Kneat, Veeva, Valgenesis, etc.)


• Previous team handling Experience is added advantage