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6 дней назад

Associate Principal QA Specialist (GMP)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
UK
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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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