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Quality Assurance Specialist
Limerick, County Limerick, Ireland · Contracter
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- Expérience
- 5 ans et plus
- Salaire
- —
- Ouvertures
- 1
- Publié
- il y a 1 heure
- Mode de travail
- Au bureau
- Éducation
- BS/BA in scientific discipline or related field
- Admissibilité
- Candidates must currently be eligible to work in Ireland and hold a Stamp 1G or Stamp 4 visa to be considered for this contract role.
- CV
- Candidature requise
Votre lieu de travail
Description de l'emploi
Overview
Join a leading biopharmaceutical company in Limerick as a Quality Assurance Specialist on a 12-month contract. This role involves ensuring quality standards across manufacturing and related areas in a high-tech facility creating innovative treatments for serious diseases.
Key Responsibilities
- Ensure comprehensive compliance of quality protocols encompassing manufacturing, quality systems, quality control, validation, facilities, and materials management at the site.
- Collaborate with multidisciplinary teams to address issues, conduct investigations, and sustain compliance.
- Review and authorize documents such as failure investigations, CAPA reports, SOPs, GxP documentation, and change controls.
- Lead and support root cause analyses and oversee CAPA implementation to prevent issue recurrence as a quality approval authority.
- Evaluate procedures, policies, and instructions related to quality systems for adherence to company standards and international regulatory requirements.
Candidate Profile
- Holds a Bachelor’s degree in a scientific discipline or related field with at least 2 years of relevant pharmaceutical or related industry experience, or an equivalent mix of education and experience.
- Demonstrates a strong background in Quality Assurance within pharmaceutical manufacturing in compliance with GMP.
Additional Information
- Contract duration: 12 months
- Location: Onsite at Limerick, Ireland
- Eligibility: Must be entitled to work in Ireland, holding Stamp 1G or Stamp 4 visa status.
- Experience required: Minimum 5 years in pharmaceutical or biotechnology sectors preferred.
Why Join
- Work on-site with prominent biopharma organizations on impactful projects.
- Receive structured onboarding ensuring readiness from day one.
- Access continuous support and regular engagement throughout the assignment.
- Become part of a wider consultant network and enjoy dedicated team assistance for project and contract navigation.
Compétences
Assurance qualité
Analyse des causes profondes
Conformité réglementaire
Good Manufacturing Practices (GMP)
Corrective and Preventative Actions (CAPA)
change control processes
Standard Operating Procedures (SOP) review
GxP documentation
Pharmaceutical Manufacturing Quality
Document Review and Approval
Styles de travail qu'ils recherchent
Communication efficace
Résolution de problèmes
travail d'équipe
Souci du détail
Collaboration interfonctionnelle