LSC have a great contract opportunity for a Quality Systems Specialist to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have at least 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
About the Role
- Act as a Subject Matter Expert (SME) within the Quality function, providing technical expertise and guidance across key quality systems and processes.
- Report to the QA Senior Manager and play a senior, hands-on role in driving compliance, quality performance, and continuous improvement initiatives.
- Apply broad QA and GMP knowledge to support quality systems, operational excellence programmes, and cross-functional projects.
- Collaborate with stakeholders across the business to ensure quality standards, regulatory requirements, and business objectives are achieved.
- Contribute to process improvements and strategic quality initiatives, with opportunities to take on additional project-based responsibilities.
- Degree-qualified in a Scientific or related discipline, with demonstrated experience across multiple quality disciplines within a regulated environment.
Main responsibilities of the role:
- Quality Systems ownership - managing and maintaining key QMS processes (Change Control, Deviations/CAPA, Documentation Management).
- Governance and oversight - participating in review boards, providing QA direction, ensuring records are robust and compliant.
- Compliance and regulatory intelligence - keeping up with changing regulations, conducting gap assessments, and maintaining inspection readiness.
- Quality Risk Management - owning QRM processes and embedding risk-based decision making.
- Continuous improvement - trend analysis, challenging existing processes, identifying improvements, and optimizing quality programs.
- Audit and inspection readiness - supporting self-inspections, audits, Quality Management Reviews, and sustained compliance initiatives.
Basic Qualifications
- University degree. Engineering or Science related discipline preferred.
- Relevant experience (3yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Note: Are you currently eligible to work in Ireland?
As this is a contract opportunity you will need to hold a valid visa - either stamp 4 or a stamp 1G with a minimum of 14 months left on it.
Apply via this advert or contact Siobhan Cummins on 021 4777329 if you have anymore questions about this role!
