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11 дней назад

Senior QA Expert CSV & Data Integrity (CSV)

Формат работы
remote (только Switzerland)/onsite
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
Switzerland
Релокация
Switzerland
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
Senior QA Expert CSV & Data Integrity (CSV): Leading data integrity assessments and computerized system validation for MES, BMS, production, and laboratory systems at a GMP-regulated manufacturing site with an accent on compliance, lifecycle management, and quality risk assessment. Focus on maintaining inspection-ready systems, managing deviations, CAPAs, and change controls, and driving data integrity improvements across local and global teams.

Location: Stein, AG, Switzerland. Primarily onsite, with remote work permitted for no more than 20% of the time. Relocation assistance is available for eligible candidates and their families.

Company

hirify.global operates globally connected life sciences and manufacturing sites that develop and manufacture medicines and therapies.

What you will do

  • Serve as the Data Integrity Ambassador for the Stein manufacturing site and lead data integrity assessments for deviations.
  • Lead and maintain Computerized System Validation activities across MES, BMS, production equipment, and laboratory equipment.
  • Validate systems for routine operations and CAPEX projects in line with validation master plans, GMP requirements, and quality standards.
  • Provide QA expertise on validation strategies, document lifecycle management, compliance, and quality risk assessments.
  • Partner with local and global stakeholders on audits, inspections, deviations, CAPAs, change controls, and continuous improvement.

Requirements

  • Proven Quality Assurance experience in a GMP-regulated environment and knowledge of pharmaceutical quality systems.
  • Hands-on experience with Computerized System Validation and lifecycle management for MES, BMS, and automation systems such as MODA or DeltaV.
  • Experience handling deviations, change management, and quality risk assessments.
  • Fluent English and the ability to collaborate with cross-functional and global stakeholders.

Nice to have

  • Experience with Data Integrity, health authority inspections, and audits involving agencies such as FDA or Swissmedic.
  • German language skills.

Culture & Benefits

  • Agile career development and a dynamic work culture.
  • Inclusive and ethical workplace with a focus on collaboration, accountability, excellence, passion, and integrity.
  • Compensation programs recognizing high performance.
  • Lifestyle, family, and leisure benefits.

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