Validation Expert
vor 2 Wochen
Project:
For our customer from the pharmaceutical industry in Kaiseraugst, we are looking for a Validation Expert (m/f/d).
Background:
The Center of Excellence Cleaning Validation is responsible for providing scientific evidence that the cleaning process of product-contacting production equipment can remove all residues to ensure that no cross-contamination occurs. Validation is based on toxicological data, sampling, and analysis of samples in our laboratories using e.g. HPLC, ELISA, TOC, and MS techniques. The trace analysis used is both developed and validated in-house. Our customers include all value streams in Kaiseraugst, Basel Biotech, and parts of the IMP area. In the Competence Center Cleaning Validation, you have numerous opportunities for further training, as we have a close connection to pharmaceutical production and are also a competence center for trace analysis.
Main tasks and areas of responsibility:
- Collaboration with internal and external interfaces (especially laboratories and value streams), practical implementation, and documentation of all cleaning validation sample trains in the companies.
- Sampling, sample preparation, compilation, evaluation, and documentation of the results of the cleaning validation sample trains carried out.
- Creating/maintaining plans, reports, sample train protocols, and SOPs.
- Ensuring that cleaning validation activities are carried out on time in compliance with all GMP requirements and processes.
- Ensuring that customer requirements in production are met in relation to the RV.
- Risk assessments on the subject of cleaning.
- ADC monitoring, spill and small scale studies, cleaning assessments.
- Launches/tech transfers in the area of cleaning validations.
- Troubleshooting in cleaning-related production processes, conducting root cause analyses, creating product quality impact assessments.
- DOC SPOC, SME for PQS documents.
- Supporting suggestions for improvement and process optimization.
- Compliance with SGU guidelines.
- Supporting team spirit and teamwork for independent work.
- Ensuring a sufficient flow of information within the team and with interfaces.
Must Haves:
- Completed university degree in the natural sciences or comparable training with many years of professional experience.
- At least 2 years of practical professional experience in the field of cleaning validation within a pharmaceutical production, especially in handling samples.
- At least 2 years of professional experience in a GMP regulated work environment.
- Experience in interface communication.
- Interest in analytics.
- Willingness to constantly develop further and take on new tasks.
- A strong ability to work in a team.
- Agile and creative way of thinking.
- Flexibility, agility, and the will to implement a lean culture.
- Good English & fluent German skills.
Nice to have:
EVAL Roche
Reference No.: 923682SDA
Role: Validation Expert (m/f/d)
Industry: Pharma
Place of work: Kaiseraugst
Workload: 80-100%
Start: 01.02.2025
Duration: 12++
Application deadline: Sunday, October 6, 2024
Job Type: 80-100%
Work Location: On the road
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