Overview
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:
- Incoming material release
- End-to-end analytical method validation
- Raw-material method validation
- Laboratory equipment qualification
