Senior Validation Specialist
vor 4 Stunden
Randstad is a leading staffing agency that supports clients in various industries, including pharmaceuticals. Our client, a pharmaceutical company based in the region, is looking for a highly skilled individual to join their team as a Qualification and Validation Engineer.
Job Description
The role of Qualification and Validation Engineer is part of the Validation Unit team and involves supporting Qualification and Cleaning/Sterilization Validation projects. Key responsibilities include:
- Executing site projects related to Qualification, CSV, Cleaning/Sterilization Validation
- Supporting coordination efforts with colleagues across the network to implement best practices and ensure site systems meet all quality and regulatory expectations.
- Developing, reviewing, and improving Qualification and CSV, Cleaning/Sterilization Validation Documentation, such as SOPs, qualification/validation documents, reports.
- Supporting compliance deliverables and technical deliverables related to qualification and validation.
- Acting as a point of contact deputy for Qualification and Cleaning/Sterilization Validation at the entire Site.
- Supporting Qualification and Cleaning/Sterilization Validation aspects during inspections.
- Implementing procedures in agreement with VU Lead.
- Simplifying processing to ensure compliance while decreasing implementation effort.
Required Skills and Qualifications
To be successful in this role, you should possess:
- A university degree in Engineering, Biotechnology, Biology, or Microbiology.
- Minimum 5 years of experience in a pharmaceutical environment with expertise in computer system validation, equipment qualification, and cleaning validation.
- Good knowledge of current GMP regulations and industrial standards.
- Experience in Auditing and Compliance within the pharmaceutical industry is preferred.
- Change and Deviation Management experience.
- Project Management skills, including prioritizing tasks, optimizing resource usage, establishing deadlines, and ensuring timely delivery.
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