QA Specialist

About the Role

Join a prominent pharmaceutical company located in Waterford, Ireland, as a Quality Assurance Specialist. This role is integral to ensuring that all products meet stringent cGMP standards during manufacturing, storage, and packaging phases. You will be actively involved in maintaining quality systems, facilitating training programs, and driving continuous improvement in a regulated environment.

Primary Responsibilities

• Guarantee compliance with current Good Manufacturing Practices (cGMP) across all production, storage, and packaging units.
• Design and implement comprehensive GMP training materials for relevant personnel.
• Draft, assess, and maintain procedural documents and batch records to ensure accuracy and compliance.
• Conduct scheduled audits covering various departments to ensure adherence to quality standards.
• Serve as the main contact for quality-related systems and workflows, providing expert advice on quality concerns.
• Review documentation, various investigations, and reports promptly, prioritizing issues based on risk assessment.
• Liaise closely with different teams to ensure swift resolution of quality actions and findings.
• Support audits both internal and external, including supplier and regulatory examinations, and participate in essential quality initiatives.
• Carry out thorough investigations into deviations, ensuring all are resolved before product release.
• Maintain cleanliness and organization of work areas aligned with good housekeeping and safety protocols.
• Track and report metrics such as Right First Time (RFT) data and analyze recurring problems for corrective measures.

Qualifications and Skills

• Possess a tertiary-level degree, ideally in a scientific or related field.
• At least two years of experience in a quality assurance role within a GMP-regulated pharmaceutical or similar setting.
• In-depth understanding of cGMP guidelines and regulatory compliance requirements.
• Exceptional attention to detail and strong interpersonal communication abilities.
• Proficient in relevant computer applications and confident in delivering presentations.
• Adaptable to change and capable of working independently as a proactive self-starter.

Personal Attributes

• Accountable and takes ownership of responsibilities.
• Effective communicator and collaborative team member.
• Focus on achieving results, emphasizing ongoing quality improvements.

Additional Information

Applicants must have lawful authorization to work in Ireland to be eligible for this role. As an employment agency, R&D Partners is dedicated to connecting outstanding candidates with leading opportunities in the life sciences sector globally.