Role Overview
A 12-month contract opportunity is available for a Senior Quality Analytical Specialist based in Dublin. In this role, you will support analytical testing for Raw Starting Materials (RSM), Intermediates, Active Pharmaceutical Ingredients (APIs), and finished Drug Products within an external manufacturing environment. You will partner with Contract Manufacturing Organizations (CMOs) and manage Contract Testing Laboratories (CTLs) as a key member of Virtual Plant Teams (VPTs).
Key Responsibilities
- Provide technical analytical expertise and troubleshooting support across external pharmaceutical manufacturing operations.
- Partner with internal and external stakeholders to schedule, oversee, and coordinate product testing across CMOs and contract laboratories.
- Serve as the primary analytical liaison for contract manufacturing and testing partners, resolving technical queries and operational issues in collaboration with cross-functional teams.
- Lead and review laboratory investigations, deviations, and Out-of-Specification (OOS) events in collaboration with technical SMEs; provide analytical input to Quality Operations and Qualified Person (QP) / Responsible Person (RP) release decisions.
- Act as Lead Investigator for major analytical deviations, maintaining tracking records in the quality management software.
- Evaluate, initiate, and manage change controls related to analytical testing across contract manufacturing sites and testing facilities.
- Facilitate communication between external analytical teams and internal global centers of excellence (e.g., Global Testing Standards, Reference Standards Management, Analytical Sciences, and Microbiology).
- Manage method transfers, spec updates, and ensure the timely distribution of reference standards and critical reagents to external sites.
- Serve as the Quality Control (QC) subject matter expert during internal and external regulatory audits.
- Collaborate with Global Stability teams and Virtual Plant Teams to oversee CMO stability programs.
- Support method validation, verification, gap analyses, and technical transfer documentation in compliance with International Council for Harmonisation (ICH) standards.
- Assist with sample tracking, Annual Product Quality Reviews (APQRs), quality agreements, data requests, regulatory submissions, and vendor RFP processes.
Qualifications & Experience
- Education: Bachelor's degree (B.A. or B.Sc.) in Life Sciences or a related discipline.
- Experience: 3-5 years of experience within a GMP Quality Control laboratory environment.
- Regulatory Knowledge: Solid understanding of global regulatory requirements, with specific familiarity with FDA and EU GMP guidelines.
- Quality Systems: Strong operational knowledge of Quality Management Systems (QMS) related to laboratory operations, investigations, and change control processes.
- Core Skills:
- Hands-on testing experience across RSM, Intermediates, APIs, and Drug Products.
- Practical knowledge of analytical method transfers, validation, and troubleshooting.
- Demonstrated ability to objectively review and critique technical investigation reports from external partners.
- Experience with electronic document and quality management systems (e.g., TrackWise, Veeva, or similar tools).
- Project management capabilities and experience managing third-party vendor relationships.
