6 дней назад
Sr. QA Validation Specialist (GxP)
54 000 - 75 600€
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr. QA Validation Specialist (GxP): Overseeing qualification and validation of facilities, utilities, and equipment for compliant medicine manufacturing with an accent on cGMP, GxP, GAMP, and European and FDA regulatory expectations. Focus on reviewing validation documentation, maintaining lifecycle traceability, managing deviations and changes, and supporting cross-functional quality improvements.
Location: Fully site-based in Geleen, Netherlands. Relocation assistance is available for eligible candidates and their families.
Salary: EUR 54,000–75,600 annual base pay.
Company
is a global life sciences organization manufacturing medicines across more than 30 sites on five continents.
What you will do
- Oversee qualification and validation activities for equipment, facilities, and utilities.
- Review and approve user requirements, validation plans, design and qualification documents, commissioning documentation, and factory and site acceptance testing.
- Maintain requirements traceability throughout the validation lifecycle through performance qualification.
- Assess validation impact and support periodic reviews, changes, and improvements to validated assets.
- Manage validation deviations, corrective actions, changes, and follow-up documentation.
- Provide cGMP and validation support to Engineering, Manufacturing, and Technical Services while contributing to process standardization.
Requirements
- 5–10 years of relevant experience in validation, quality assurance, quality control, control systems, or a related field within regulated manufacturing.
- Technical diploma or bachelor's or master's degree in Engineering, Biology, Biomedical Science, Life Science, or a related discipline.
- Practical knowledge of validation methodologies, including DQ, IQ, OQ, and PQ.
- Experience with cGMP, GxP, GAMP, quality systems, and European and FDA regulatory expectations.
- Strong analytical, problem-solving, communication, organizational, and time-management skills.
Culture & Benefits
- Agile career environment and dynamic working culture.
- Inclusive and ethical workplace focused on collaboration, accountability, excellence, passion, and integrity.
- Performance-based compensation programs and benefits dependent on role and location.
- Opportunities to contribute to continuous improvement and international standardization.
- Close collaboration across Quality Assurance, Engineering, and Manufacturing in person.
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