8 дней назад
Batch Release Lead Qualified Person (Biopharma)
73 200 - 97 600€
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Batch Release Lead Qualified Person (Biopharma): Certifying and releasing sterile pharmaceutical batches in compliance with cGMP requirements, while overseeing quality systems and site-wide improvement initiatives with an accent on Annex 1 compliance, quality documentation, and batch certification. Focus on investigating product issues, resolving quality actions, mentoring QA specialists, and ensuring safe, timely product release.
Location: Waterford, Ireland; 3 days onsite and 2 days remote per week. Candidates must be based in Ireland.
Salary: €73,200–€97,600 per year.
Company
is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines.
What you will do
- Certify and release sterile pharmaceutical batches while ensuring compliance with cGMP requirements.
- Review and approve quality documentation and investigate product issues before release.
- Collaborate with cross-functional teams to resolve quality issues and close corrective actions.
- Lead site-wide quality process improvement projects.
- Guide and mentor QA specialists and support their professional development.
- Follow site safety procedures and escalate safety concerns.
Requirements
- Previous experience as a Qualified Person certifying and releasing batches under a manufacturing licence.
- Experience with sterile product manufacturing and current regulatory requirements, including Annex 1.
- Master’s degree or Pharmacy qualification meeting Qualified Person eligibility criteria through an Ireland-based qualification or UK equivalent.
- Fluent English and current residence in Ireland required.
- Strong communication, influencing, follow-through, and results-oriented skills.
- Ability to work onsite according to production schedules is required.
Culture & Benefits
- Work with AI, robotics, digital technologies, and next-generation automation in pharmaceutical manufacturing.
- Contribute to smart factory, resilient supply chain, and new product launch initiatives.
- Develop skills and explore cross-functional opportunities in a growth-oriented environment.
- Participate in employee benefit programs.
- Equal-opportunity and disability-confident workplace.
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