QC Compliance Engineer

Coalesce Management Consulting; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Coalesce Management Consulting is seeking a QC compliance professional with practical experience in incoming material release, analytical method validation, and laboratory equipment qualification within a GMP-regulated QC environment.

The successful candidate will support quality and compliance activities, ensuring laboratory processes, documents, and systems meet regulatory standards. Strong collaboration across QC, QA, and warehouse teams is essential to maintain inspection readiness.

Qualifications

• Experience with incoming raw-material release in a GMP/pharma/biotech setting.
• Knowledge of the method-validation lifecycle and its application.
• Experience validating raw-material analytical methods.
• Exposure to equipment qualification and related documentation.
• GMP documentation practices and quality-system compliance.
• Strong attention to detail and cross-functional collaboration.
• Clear written and verbal communication skills.

Responsibilities

• Support incoming material release activities through QC documentation review.
• Manage the analytical method validation lifecycle from protocol to closure.
• Apply validation principles to raw-material testing methods.
• Support equipment qualification activities and documentation review.
• Prepare and maintain GMP-compliant QC documentation.
• Collaborate with QC, QA, warehouse, and stakeholders to resolve issues.
• Maintain inspection readiness and adhere to site procedures.

Skills

Incoming material release

Method validation lifecycle

Raw-material analytical methods

Equipment qualification

GMP documentation

Quality systems

Communication

Stakeholder collaboration

Education

Degree in Chemistry

Job description

We are seeking a QC compliance professional with practical experience in incoming material release, analytical method validation, and laboratory equipment qualification. The successful candidate will support quality and compliance activities within a GMP-regulated QC environment, ensuring laboratory processes, documentation, and systems meet required standards.

Key Responsibilities

• Support and coordinate incoming material release activities, including review of associated QC documentation and test status.
• Manage or contribute to the full analytical method validation lifecycle, from protocol preparation through execution, data review, reporting, and closure.
• Apply method-validation principles to raw-material testing methods, including selection and assessment of appropriate validation parameters.
• Support equipment qualification activities for laboratory equipment, including documentation review and ongoing compliance requirements.
• Prepare, review, and maintain GMP-compliant QC documentation, including protocols, reports, records, and supporting quality documents.
• Work closely with QC laboratory, Quality Assurance, warehouse/materials, and other relevant stakeholders to resolve compliance or release-related issues.
• Maintain inspection readiness and follow site quality procedures and applicable regulatory expectations.

Required Experience and Skills

• Demonstrable experience with incoming raw-material release in a GMP, pharmaceutical, biotech, or similarly regulated manufacturing environment.
• Strong working knowledge of the method validation lifecycle, including the ability to explain, plan, execute, review, or support validation work.
• Experience validating or supporting validation of raw-material analytical methods.
• Exposure to laboratory equipment qualification, including an understanding of qualification requirements across different equipment types.
• Good understanding of GMP documentation practices, data review, deviation awareness, and quality-system compliance.
• Strong attention to detail, organisation, and ability to work across multiple quality and laboratory stakeholders.
• Clear written and verbal communication skills.

Preferred Qualifications

• Degree in Chemistry, Pharmaceutical Science, Life Sciences, Biotechnology, or a related discipline.
• Experience in a QC, QA, analytical development, or validation-focused role.
• Familiarity with common validation expectations and guidance, such as ICH-aligned analytical validation principles.
• Experience working with both routine laboratory equipment and more complex analytical systems.

What We’re Looking For

The interview placed the strongest emphasis on candidates who can demonstrate practical capability - not just theoretical awareness - in: