Senior QA Lead: GMP Compliance & CAPA

p-con management pte. ltd.

Singapore

On-site

SGD 60,000 - 90,000

Full time

9 days ago
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Job summary

P-Con Management Pte. Ltd. in Singapore seeks a QA professional to provide day-to-day support for a multi-product cGMP facility, ensuring SOP and policy compliance, and contributing to data integrity and continuous improvement.

You will review and approve GMP documentation, lead CAPA and deviations reviews, support audits and validations, mentor junior staff, and collaborate across functions to drive quality and timelines.

Qualifications

  • Degree in Biological Science / Engineering and experience in Quality unit in the Biopharmaceutical industry.
  • 3-4 years of experience in a similar type of industry or a similar job role.
  • Able to operate independently with minimum supervision.
  • Fair knowledge and experience of the practical and theoretical requirement of quality management system in a GMP facility
  • Team player, with strong focus on safety, quality and timelines

Responsibilities

  • Provide day-to-day QA support and oversight for a multi-product cGMP manufacturing facility, ensuring compliance with SOPs and policies.
  • Review and approve GMP documentation (deviations, investigations, CAPAs, change controls, SOPs, protocols, reports, MBRs), driving effective root cause analysis and timely CAPA closure.
  • Identify and elevate cGMP non-compliance, troubleshoot quality issues, and make risk-based decisions.
  • Provide QA oversight for changeovers, operational/process changes, and validation activities (VMP, PPQ, protocols/reports, CPV).
  • Participate in regulatory and customer audits, and support data integrity and process improvement initiatives.
  • Lead small projects, coordinate cross-functionally, mentor junior QA staff, and act as a qualified trainer, reviewer, approver, or change agent as required.

Skills

QA oversight
GMP awareness
Regulatory audits
Independent work
Team collaboration

Education

Degree in Biological Science / Engineering

Job description

P-Con Management Pte. Ltd. in Singapore seeks a QA professional to provide day-to-day support for a multi-product cGMP facility, ensuring SOP and policy compliance, and contributing to data integrity and continuous improvement.

You will review and approve GMP documentation, lead CAPA and deviations reviews, support audits and validations, mentor junior staff, and collaborate across functions to drive quality and timelines.

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