Requirements: English
Company: K-Recruiting Life Sciences
Region: Werthenstein , Lucerne
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Tasks:
- Executes site projects related to Qualification, CSV, Cleaning/Sterilization Validation.
- Support coordination efforts with colleagues across the network to implement best practices and ensure site systems meet all quality and regulatory expectations.
- Support for the development, review, and improvement of Qualification and CSV, Cleaning/Sterilization Validation Documentation, such as SOPs, qualification/validation documents, and reports.
- Support for compliance deliverables and technical deliverables related to qualification and validation.
- Act as a point of contact deputy for Qualification and Cleaning/Sterilization Validation at the entire WAG Site.
- Support with Qualification and Cleaning/Sterilization Validation aspects during inspections.
- Support the implementation of procedures in agreement with VU Lead.
- Support the areas implementation of process changes and root cause investigation of deviations.
- Support the evaluation of innovative equipment/technologies with respect to Qualification, CSV, Cleaning/Sterilization Validation, reviewing user requirements.
- Support to identify and harmonize practices across the site in relation to Qualification and Cleaning/Sterilization Validation.
Qualifications:
- University degree preferable in Engineering, Biotechnology, Biology, or Microbiology.
- Minimum 5 years of experience in the pharmaceutical environment with experience 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 preferred.
- Change and Deviation Management experience.
- Project Management skills: organizes work efforts by prioritizing tasks, using resources optimally, establishing appropriate deadlines, and ensuring on-time delivery.
- Strong communication skills: Plans and delivers ideas and information to others in a clear and impactful manner.
Requirements:
Start: 02.02.2025
Duration: 12 months
Seniority Level
Mid-Senior level
Employment Type
Full-time
Job Function
Pharmaceutical Manufacturing
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