Назад
Company hidden
5 дней назад

Senior QA Specialist, QA Analytics 80-100% (f/m/d)

Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Switzerland
Релокация
Switzerland
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:
/
TL;DR
Senior QA Specialist, QA Analytics 80-100% (f/m/d) (GMP analytics): Ensuring quality oversight for GMP-relevant QC and Analytical Development activities, with an accent on SOPs, analytical methods, validation, and pharmacopoeial compliance. Focus on reviewing investigations, deviations, changes, and CAPAs, supervising out-of-specification events, and supporting audits and health authority interactions.

Location: Visp, Switzerland. Relocation assistance is available for eligible candidates and their families.

Company

hirify.global is a global life sciences company manufacturing medicines across more than 30 sites on five continents.

What you will do

  • Provide QA oversight to Quality Control and Analytical Development activities and ensure GMP requirements and SOPs are followed.
  • Control and release GMP-relevant QC and Analytical Development documentation.
  • Review and approve SOPs, analytical test methods, method transfer and validation protocols and reports, and gLIMS investigations.
  • Supervise investigations of out-of-specification, out-of-expectation, and out-of-trend results.
  • Own and revise SOPs, and ensure compliance in stability testing and reference standards.
  • Review deviations, investigations, change requests, and CAPAs, while supporting inspections and audits.

Requirements

  • Academic degree in Chemistry, Biotechnology, Life Sciences, or a related field.
  • Significant pharmaceutical industry experience, preferably in QC or QA.
  • Strong analytical expertise and experience with analytical method validation.
  • Strong knowledge of cGMP regulations, including USP, European Pharmacopoeia, and Japanese Pharmacopoeia.
  • Auditing experience and experience interacting with health authorities such as FDA and Swissmedic.
  • Excellent written and verbal English communication skills.

Nice to have

  • Knowledge of German.

Culture & Benefits

  • Agile career development and a dynamic working culture.
  • Inclusive and ethical workplace.
  • Performance-based compensation programs.
  • Benefits that depend on the role and location.
  • Relocation assistance for eligible candidates and their families.

Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →