GMP CQV Lead: Validation & Commissioning Expert

Coalesce Management Consulting Pte. Limited; Singapore; On-site; SGD 140,000 - 190,000; Full time

Job summary

Coalesce Management Consulting Pte. Limited is seeking a C&Q Lead to provide validation oversight and hands-on support for a 5kL manufacturing project in a GMP-regulated environment.

You will lead commissioning and qualification activities, support cleaning validation, and assist with site projects. The ideal candidate has significant CQV experience, strong technical writing skills, and the ability to guide cross-functional teams, including Engineering, Manufacturing, Quality, and Vendors.

Qualifications

• Strong hands-on experience with equipment and manufacturing CQV activities.
• Knowledge of validation lifecycle: DQ/IQ/OQ/PQ and deviations.
• Ability to review P&IDs, equipment specs, and vendor packages.
• Proven ability to coordinate resources and guide validation teams.
• Excellent technical writing, planning, and stakeholder management.

Responsibilities

• Lead and oversee commissioning, qualification, and validation for the 5kL project.
• Develop and approve validation plans, URS, risk assessments, IQ/OQ/PQ protocols, and reports.
• Ensure CQV activities comply with GMP and data integrity requirements.
• Review engineering docs, vendor packages, turnover packages and calibration certificates.
• Coordinate protocol execution and provide guidance to validation engineers and contractors.
• Oversee equipment and manufacturing-system qualification incl. utilities and automation.
• Support cleaning- validation with protocol review and oversight.
• Investigate and resolve qualification discrepancies and test failures.
• Contribute validation input to change controls, risk evals, and system releases.
• Monitor progress and communicate risks and actions to stakeholders.
• Ensure documentation is complete, traceable, and inspection-ready.

Skills

CQV experience

Technical leadership

Documentation & reports

Education

Engineering degree

Pharmaceutical Science / Life Sciences

Job description

Coalesce Management Consulting Pte. Limited is seeking a C&Q Lead to provide validation oversight and hands-on support for a 5kL manufacturing project in a GMP-regulated environment.

You will lead commissioning and qualification activities, support cleaning validation, and assist with site projects. The ideal candidate has significant CQV experience, strong technical writing skills, and the ability to guide cross-functional teams, including Engineering, Manufacturing, Quality, and Vendors.