QC Analyst

About the Role

R&D Partners is recruiting a QC Analyst for a rapidly expanding, internationally recognized pharmaceutical manufacturer located in Tipperary, Ireland. The company operates a modern facility dedicated to the development and manufacture of complex and high-value medicines, including inhalation and specialty therapies. The role presents a unique chance to contribute to the site's transition into a fully commercial manufacturing operation with continued investment in production and research capabilities. Candidates must have the legal right to work in Ireland.

Key Responsibilities

• Conduct verification, validation, and technical transfer of analytical methods.
• Support the setup of laboratory facilities and operations.
• Draft laboratory protocols, procedures, specifications, and related reports as needed.
• Perform laboratory testing and investigations adhering to SOPs, applicable regulations, and cGMP standards.
• Carry out peer reviews for laboratory documentation.
• Manage laboratory consumables including placing orders and inventory tracking.
• Assist with equipment qualification processes.
• Support preparation for regulatory audits and ensure ongoing audit readiness.
• Coordinate with Contract Research Organizations (CROs) and conduct audits when required.
• Maintain compliance with internal policies, cGMP, and regulatory standards.
• Ensure cleanliness and organization within the workplace to protect product integrity.
• Execute calibration of analytical balances as necessary.
• Collaborate effectively with cross-functional teams including technicians, engineers, and operations personnel.

Qualifications and Experience

• 2 to 5 years of experience working in GMP-regulated QC laboratories within pharmaceutical or biotechnology sectors.
• Strong hands-on experience with analytical instruments such as HPLC, GC, and analytical balances, as well as method validation, verification, or transfer activities.
• Solid knowledge and experience performing analytical tests in compliance with SOPs, cGMP, and regulatory requirements.
• Proficient in data review and strict adherence to Good Documentation Practices (GDP).
• Capability to support investigations related to deviations, CAPA processes, and root cause analysis.
• Experience participating in regulatory inspections, audits, or maintaining audit readiness.

Additional Information

If interested in this opportunity, candidates can contact the recruiter directly. This position is offered through R&D Partners, a life sciences recruitment specialist engaged as the employment agency for this vacancy. Applicants confirm their understanding of the company's privacy policy regarding data protection by applying.