Contract QA Specialist – Pharma/Biotech (Ireland)

PSC Biotech Corporation; Tipperary; On-site; EUR 60,000 - 75,000; Full time

Job summary

PSC Biotech Corporation in Ireland is seeking a Contract Associate Quality Specialist to support day-to-day QA activities within the Quality Systems CoE, ensuring robust compliance with global cGMP standards. This role will oversee deviation investigations, CAPA, supplier qualification, and QA support for analytical/microbial labs, including environmental monitoring and validation oversight.

The 11-month contract offers exposure to top pharmaceutical client sites, collaboration across

Qualifications

• Degree or postgraduate qualification in Chemistry, Microbiology, Biology, Science, Pharmacy, Engineering, or a related technical discipline.
• 3+ years of Quality Assurance, Quality Systems, or Laboratory QC/Microbiology experience in a highly regulated GxP pharmaceutical or biopharmaceutical manufacturing environment.
• Experience reviewing analytical/microbiological laboratory investigations (OOS/OOT), laboratory change controls, stability protocols, environmental monitoring data, or sterility assurance parameters.
• Knowledge of method validation, verification, and transfer principles.

Responsibilities

• Deviation Trending & Support: QA oversight for deviation investigations and root-cause analysis.
• CAPA Management: Define and execute effective corrective and preventive actions.
• Customer Complaint Management: Coordinate investigations and draft reports with cross-functional teams.
• Annual Reviews: Prepare product, process, and system reviews for regulatory compliance.
• Analytical & Microbiological QA Support: QA partner for labs, review change controls and validation data.
• Validation, Equipment & GMP Compliance: oversight of IQ/OQ/PQ and regulatory submissions.

Skills

Quality Assurance

CAPA Management

Deviation Investigation

GxP Compliance

Supplier Qualification

Education

Chemistry / Microbiology / Biology

Tools

SAP Master Data

Kneat

ProCal

Lab Software

Job description

PSC Biotech Corporation in Ireland is seeking a Contract Associate Quality Specialist to support day-to-day QA activities within the Quality Systems CoE, ensuring robust compliance with global cGMP standards. This role will oversee deviation investigations, CAPA, supplier qualification, and QA support for analytical/microbial labs, including environmental monitoring and validation oversight.

The 11-month contract offers exposure to top pharmaceutical client sites, collaboration across