Quality Control Specialist
Join VLE Therapeutics, a company powered by transformation research in APC, dedicated to delivering science and digital-led manufacturing of vaccines and advanced therapeutics. Our mission is to support GMP clinical manufacturing of these medicines, providing Ireland and Europe with a local supply chain for critical medicines in a modern, Irish-owned facility.
We are seeking a Quality Control Specialist to develop and oversee QC operations within our GMP manufacturing environment. This role offers a unique opportunity to work on ATMP and related pharmaceutical developments in a collaborative and innovative setting.
Principal Responsibilities
1. Develop QC requirements for GMP manufacturing, including testing protocols, sampling plans, and engagement with outsource QC suppliers.
2. Execute process, environmental, and facilities monitoring, sampling, and testing in line with GMP standards.
3. Create and maintain documentation supporting QC activities (SOPs, test methods, sampling plans, CoA’s, LIR, protocols, reports) and review analytical data.
4. Provide laboratory support across departments, ensuring GMP/GLP standards are upheld.
5. Collaborate with team members, communicate proactively, and support investigations into analytical failures using structured problem-solving and root cause analysis.
6. Develop and evaluate analytical training programs and train new laboratory personnel.
7. Assist in project management of analytical activities and identify improvement opportunities.
8. Set up, maintain, and properly use analytical equipment and systems (e.g., LIMS, LabX, UV software).
9. Maintain laboratory 6S standards and good housekeeping practices.
Experience & Qualifications
* Minimum 2 years' GMP pharma QC operations experience.
* Ability to perform QC activities in a cGMP manufacturing environment.
* Primary degree in a scientific discipline or equivalent; relevant postgraduate qualification is an advantage.
* Effective within cross-functional teams with strong organizational skills and self-direction.
How to Apply
Applicants should submit a CV and cover letter by 31st May 2025. VLE is committed to equal opportunity employment, considering all applicants based on merit without discrimination.
Salary: Negotiable
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