QC Analyst

A QC Analyst is required for a leading pharmaceutical Company based in Waterford This is a 23 month contract. In this role, you will provide critical analytical chemistry testing and operational support to ensure full compliance with cGMP/cGLP standards and support the timely release of raw materials, intermediates, and finished products .

THE ROLE

• Perform and review analytical chemistry testing and laboratory data in compliance with cGMP, cGLP, and data integrity standards.

• Lead investigations into Out-of-Specification (OOS) results, generate Certificates of Analysis (CoAs), and support ongoing data trending.

• Maintain, update, and review analytical methods, specifications, laboratory notebooks, and SOPs in line with evolving regulatory standards.

• Support installation, operational, and performance qualifications (IQ/OQ/PQ) for laboratory instrumentation.

• Train analysts on laboratory methods, updated SOPs, and testing procedures.

• Partner effectively with QA, Production, Engineering, Planning, and QC teams to drive operational success.

REQUIREMENTS

• Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline (or equivalent experience).

• Proven analytical chemistry experience within a GMP-regulated environment.

• In-depth understanding of cGMP/cGLP guidelines and data integrity principles.

• Strong track record in data review, investigation documentation, and technical record-keeping.

• Excellent cross-functional communication and collaborative problem-solving skills.

Preferred Technical Experience

• ELISA, SDS-PAGE, Biacore receptor-binding assays, UV analysis, Osmolality, Karl Fischer moisture testing, Oxygen headspace analysis, and HIAC particulate testing.

• SoftMax® software proficiency, precision micropipetting techniques, and strong time management skills.

Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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