Senior Quality Engineer – Computer System Validation
Bekijk en reageer bij SIRE Life Sciences B.V. (externe link)
Senior Quality Engineer (CSV) voor MES-projecten in de farmaceutische sector, Hoofddorp, start 8 juli 2026.
- Locatie
- Hoofddorp
- Werkvorm
- op locatie
- Uren
- 40 uur per week
- Contractvorm
- detachering
- Startdatum
- Eerste waarneming
Eisen
- Ability to work independently on routine tasks and manage multiple priorities
- Proven experience in computer system validation within regulated environments
- Strong understanding of GMP and regulatory standards
- Ability to review and approve validation deliverables
- Good communication and collaboration skills
Omschrijving
A leading organization in the healthcare and manufacturing industry is seeking a skilled Senior Quality Engineer specializing in Computer System Validation (CSV) to join their team. This role is vital in supporting MES projects, ensuring compliance, and maintaining the integrity of validation activities across the organization. Responsibilities include supporting the development and tracking of KPIs to drive continuous improvement initiatives, developing strategies to implement changes to processes and procedures, reviewing and approving all CSV validation deliverables (including initial qualification, change control validation, and periodic revalidations), building a working knowledge of products and contracts to ensure quality standards are met, collaborating effectively with cross-functional teams, prioritizing tasks to meet departmental goals, ensuring compliance with regulatory requirements and maintaining GMP standards, developing solutions for complex problems, evaluating deviations and assessing their impacts, overseeing inspections, statistical process control analyses, and audits to enforce quality requirements, and supporting compliance audits and contributing to quality oversight activities including CQV and Risk Management. Requirements include proven experience in computer system validation within regulated environments, strong understanding of GMP and regulatory standards, ability to review and approve validation deliverables, good communication and collaboration skills, and ability to work independently on routine tasks and manage multiple priorities. The position is located in Hoofddorp, Noord-Holland, in the Pharmaceuticals sector, with a start date of 8 July 2026. Job reference 58654.
Alle opdrachtenBekijk en reageer bij SIRE Life Sciences B.V. (externe link)
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