6 дней назад
Associate Principal QA Specialist (GMP)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Principal QA Specialist (GMP): Providing QA oversight for QC, MSAT, and Development Services activities, including GMP reviews, quality investigations, audits, and regulatory compliance with an accent on quality systems, risk-based issue resolution, and technical operations. Focus on managing deviations, CAPAs, change controls, OOS records, inspections, and continuous improvement while acting as a GMP subject matter expert.
Location: Fully site-based in Slough, UK
Company
Global life sciences and manufacturing organization developing and manufacturing medicines through connected sites across five continents.
What you will do
- Review, approve, and provide guidance on deviations, CAPAs, change controls, investigations, and OOS records.
- Manage and escalate major and critical GMP compliance issues through the Quality Management System and governance forums.
- Provide QA oversight for QC, MSAT, and Development Services activities, including method validation, reference standards, technology transfer, and stability programs.
- Act as a GMP subject matter expert and provide quality guidance to Operations, QC, MSAT, and Development Services.
- Mentor team members and business partners in cGMP principles while promoting continuous compliance.
- Maintain audit readiness and drive quality system improvements through walkthroughs, audits, inspections, and cross-functional initiatives.
Requirements
- BSc or equivalent experience in a scientific subject is preferred.
- Experience developing and implementing quality assurance plans for technical operations.
- Expertise in auditing and inspecting technical processes.
- Ability to identify non-conformances and initiate corrective actions.
- Experience implementing quality improvements with technical teams and reporting quality metrics.
- Outstanding written, oral, interpersonal, and active listening skills.
Culture & Benefits
- Agile career environment and dynamic working culture.
- Inclusive and ethical workplace committed to diversity.
- Performance-recognition compensation programs.
- Benefits vary according to role and location.
- In-person collaboration supports real-time teamwork and technical precision in medicine manufacturing.
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