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.
Coalesce Management Consulting(CMC) is a leading international consulting partner providing technology, business change, outsourcing and operational support services across the engineering, energy, life sciences and technology sectors