23579 - QA Specialist

Orion Group Life Sciences are currently recruiting a Quality Assurance Specialist on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 6-Month contract with potential to extend.

A leading biopharmaceutical organization is seeking a Quality Assurance Specialist to join its External Quality Vaccines team. This individual will play a key role in ensuring that all externally manufactured vaccine products meet the highest standards of quality and comply with global regulatory requirements.

This opportunity involves supporting a global manufacturing network of external contractors, suppliers, and partners to ensure the reliable and timely delivery of high-quality vaccines to customers and patients worldwide.

Role Summary

The Senior Specialist – External Quality Vaccines will act as Product Quality Manager (PQM) and will be responsible for overseeing the quality aspects of vaccine manufacturing, packaging, testing, release, storage, and distribution carried out by external partners. This includes ownership of batch release decisions, oversight of quality systems, and risk-based quality management of external manufacturing operations.

Key Responsibilities

• Evaluate and/or release products to other manufacturing sites and/or to market, ensuring conformance with internal standards and global regulatory requirements.
• Review and approve quality-related documentation such as change controls, deviations, complaints, and validation reports.
• Lead or support investigations into complex quality issues and ensure appropriate corrective and preventive actions (CAPAs) are developed.
• Manage and review stability programs and Annual Product Reviews (APRs).
• Oversee and assess external partners' quality systems and operational performance using metrics and on-site supervision.
• Support regulatory filings, including documentation for pre-approval inspections (PAIs) and post-approval changes.
• Ensure effective management of retention samples, reagent/sample shipments, and quarantine product shipments.
• Provide quality support for process validation, technology transfer, and product lifecycle management.
• Serve as a key quality contact for external manufacturing partners.

Qualifications & Experience

• Bachelor's or Master’s degree in Science, Engineering, or a related discipline.
• Strong background in Quality Assurance, Quality Control, and GMP compliance within the pharmaceutical or biopharmaceutical industry.
• Proven ability to independently manage complex quality investigations and regulatory documentation.
• Experience providing quality oversight for external manufacturers or contract partners.
• In-depth knowledge of global GMP quality systems and regulatory expectations.
• Skilled in Quality Risk Management (QRM) and problem-solving in a regulated environment.
• Effective communicator with excellent written and verbal English language skills.
• Demonstrated interpersonal and cross-functional collaboration skills.

Preferred Experience

• Experience with biologics or vaccine manufacturing, particularly aseptic operations.
• Familiarity with regulatory submissions such as BLAs or NDAs.
• Knowledge in analytical method validation, transfer, and analytical standards.
• Competency in facility/equipment qualification (IQ/OQ/PQ) and process/cleaning validation.
• Previous exposure to rapid microbiological methods, sterility testing, or vaccine-specific quality processes is an advantage.

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.