Quality Assurance Compliance Specialist
CR/077320
Posted: 24/04/2025
- Competitive
- Ireland, County Sligo, Sligo
- Contract
Orion Group Life Sciences are currently recruiting a QA Manufacturing Compliance Specialist on behalf of our Multinational Biopharmaceutical Client based in Co. Sligo on an initial 12-Month contract with potential to extend.
Schedule: Rotating Shifts (Days: 07:00–15:00 | Evenings: 15:00–23:00 with 16.7% Shift Premium)
Work Arrangement: Onsite Role
Key Responsibilities
Requirements
Accountability & Decision-Making
Collaboration & Leadership
EHS Responsibilities
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Schedule: Rotating Shifts (Days: 07:00–15:00 | Evenings: 15:00–23:00 with 16.7% Shift Premium)
Work Arrangement: Onsite Role
Key Responsibilities
- Ensure all finished products meet required standards for both commercial and investigational drug products.
- Oversee compliance of products and aseptic process simulations to meet regulatory and internal requirements.
- Provide quality oversight to manufacturing operations, ensuring adherence to site procedures and policies.
- Support aseptic manufacturing activities, including direct observation of aseptic interventions.
- Lead or assist in investigations related to non-compliance in products or processes.
- Review and audit completed batch records and manufacturing documentation.
- Conduct quality reviews of SOPs, risk assessments, and operational documents.
- Carry out line clearance activities and incoming raw material checks as needed.
- Provide support to the stability program, including sample pulls and protocol preparation.
- Maintain finished product status and ensure proper labelling.
- Administer quality logs (QA Hold, Sample Requests, etc.).
- Lead daily QA walkthroughs on the production floor.
- Identify opportunities for continuous improvement and ensure ongoing compliance with site standards.
Requirements
- Bachelor’s degree in science, Quality, Engineering, or a related field.
- At least 3 years of experience in a GMP-regulated environment in a quality or operations capacity.
- Previous experience in biologics manufacturing and aseptic processing is highly desirable.
- Solid understanding of regulatory requirements and quality systems.
- Strong attention to detail and commitment to compliance.
- Effective problem-solving and decision-making abilities.
- Capable of driving innovation and improvements in processes.
- Excellent communication and interpersonal skills.
- Results-oriented, with a focus on meeting quality and performance targets.
- Demonstrates integrity and a high standard of professionalism.
- Ability to work independently with minimal supervision.
Accountability & Decision-Making
- Operates with a high level of autonomy and initiative.
- Accountable for ensuring product quality and operational compliance.
- Makes decisions within the scope of quality systems and regulatory standards.
- Consults with senior personnel or team leads for complex or escalated issues.
Collaboration & Leadership
- May participate in cross-functional teams and continuous improvement projects.
- Provides guidance to operations teams to resolve quality concerns and drive compliance.
- Acts as a subject matter expert on compliance matters within the site.
EHS Responsibilities
- Comply with all EHS policies and procedures.
- Actively promote a culture of safety and report any incidents or near misses.
- Participate in required safety training and medical surveillance programs.
- Use personal protective equipment (PPE) as required.
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Aoibhinn Daly
Recruitment Consultant
Apply for this role
Recruitment