9 дней назад
Specialist QA (Pharmaceutical)
67 814 - 91 748€
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Specialist QA (Pharmaceutical) (GMP/GDP, SAP, LIMS): Managing batch disposition and quality records for contract manufacturers within a global supply quality function with an accent on cGMP documentation, investigations, and supplier-related changes. Focus on driving deviations and investigations to closure, reviewing complaint assessments, and maintaining compliance with manufacturing and distribution requirements.
Location: Dublin, Ireland
Salary: €67,813.85–€91,748.15 per year
Company
operates a Global Supply Quality team supporting oversight and maintenance of contract manufacturers.
What you will do
- Manage batch disposition activities in line with company quality standards.
- Drive quality records, including deviations and investigation reports, to closure.
- Initiate quality records for supplier-related changes and collaborate with the Complaints team on assessments and report reviews.
- Provide data supporting quality management processes across the network.
- Prepare, review, and approve SOPs and GMP/GDP documentation in accordance with corporate and regulatory requirements.
- Contribute to quality improvement initiatives and communicate quality objectives and compliance needs to stakeholders.
Requirements
- Master’s degree, or a Bachelor’s degree with 2 years of directly related experience, or an Associate’s degree with 6 years of experience, or a high school diploma/GED with 8 years of experience.
- Deep knowledge of SAP and LIMS systems.
- Experience with GMP software such as Veeva or TrackWise.
- Basic understanding of supply chain and logistics processes.
- Strong technical writing skills for cGxP documentation, including investigations, procedures, and change controls.
- Ability to work independently, manage multiple priorities, and deliver accurate results on time.
Nice to have
- 5+ years of quality and manufacturing experience in the biotech or pharmaceutical industry.
- Bachelor’s degree in a science field and cGMP experience.
- Familiarity with basic project management tools.
- Understanding of API, drug substance, drug product, packaging, or device manufacturing and testing processes.
- Experience working in a matrixed or team environment.
Culture & Benefits
- Full-time role within a global supply quality function.
- Collaboration with manufacturing, complaints, network, and other stakeholder groups.
- Participation in operational and quality improvement programs and projects.
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