C&Q Compliance Support (Mid - Senior Level)

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
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