Quality Control Analyst

CareerWise Recruitment; Waterford; Sur place; EUR 45 000 - 70 000; Plein temps

Résumé du poste

CareerWise Recruitment is seeking a QC Analyst for a leading pharmaceutical company in Waterford on a 23-month contract. You will perform analytical chemistry testing to ensure compliance with cGMP/cGLP and support timely release of materials and finished products.

Responsibilities include leading OOS investigations, preparing CoAs, updating methods and SOPs, and training staff while partnering with QA, Production, Engineering, Planning and QC teams.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, or a related scientific discipline.
• 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.

Responsabilités

• Perform and review analytical chemistry testing in compliance with cGMP/cGLP standards.
• Lead investigations into OOS results, generate CoAs, and support data trending.
• Maintain, update, and review analytical methods, specifications, notebooks, and SOPs.
• Support IQ/OQ/PQ for laboratory instrumentation.
• Train analysts on laboratory methods, updated SOPs, and testing procedures.
• Partner with QA, Production, Engineering, Planning, and QC teams to drive operational success.

Connaissances

Analytical chemistry

GMP experience

Data integrity

Documentation & investigations

Cross-functional collaboration

Formation

Bachelor’s degree in Chemistry or related field

Outils

SoftMax® software

Karl Fischer testing

Elisa/UV analysis

Osmolality testing

HIAC particle testing

Description du poste

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.