Flexiforce, a Hartley people company are currently working with our well establishes client in Waterford City, for someone to join their team as Quality Assurance on a temporary 6 month contract.
ROLE PURPOSE
To ensure the organisation maintains full regulatory and GMP compliance across R&D operations through timely batch review, effective quality system oversight, and support for new product, process, and system validation.
KEY RESPONSIBILITIES
Quality & Compliance
- Maintain and enhance quality systems to ensure alignment with cGMP, cGLP, cGCP, SOPs, and regulatory expectations.
- Review and approve change controls, quality records, and associated documentation.
- Support investigations, deviation reduction activities, and continuous improvement initiatives.
- Provide input into customer complaint assessment and resolution.
Operational Support
- Review and release batch documentation, ensuring compliance with regulatory and internal standards.
- Support clinical and development product activities, ensuring adherence to EU, US, and global regulatory requirements.
- Assist in equipment qualification, validation protocols, and ongoing product maintenance.
Systems & Validation
- Ensure computerised systems affecting product quality are validated and documented to GMP and technical requirements.
- Support validation activities for new equipment, facilities, products, and temperature mapping programmes.
Audit & Stakeholder Engagement
- Support internal and external audits, including simulated regulatory inspections.
- Conduct vendor audits and contribute to supplier approval processes.
- Collaborate with internal functions including R&D, QA, operations, technology, and Qualified Persons.
IMPACT
- Ensures timely product release and shipment.
- Sustains regulatory and license compliance.
- Maintains product quality and vendor oversight.
QUALIFICATIONS
- Degree or diploma in pharmaceutical or life sciences.
- Minimum two years’ experience in Quality Assurance or validation.
- Experience participating in regulatory or customer audits.
SKILLS & CAPABILITIES
- Strong understanding of cGMP and regulatory standards.
- Skilled in technical writing, investigation, project management, and continuous improvement.
- Effective planning and prioritisation skills; able to work independently or within teams.
- Strong communication and stakeholder engagement abilities.
- Skilled in computer-based systems; experience with business systems (e.g., SAP) an advantage.
DECISION AUTHORITY
- Approval of deviations, CAPA, investigations, SOPs, validation protocols, and associated reports.
- Shared authority for product release decisions and complaint responses.
STANDARDS
- Compliance with cGMP, cGLP, and applicable EU, FDA, and international regulations.
- Adherence to internal procedures and policies.
Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. If you meet the criteria for this position, we will provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your consent.