Pharma QC Analyst: cGMP, Data Integrity & Investigations

CareerWise Recruitment; Waterford; On-site; EUR 45,000 - 70,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Analytical chemistry

GMP experience

Data integrity

Documentation & investigations

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry or related field

Tools

SoftMax® software

Karl Fischer testing

Elisa/UV analysis

Osmolality testing

HIAC particle testing

Job description

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.