Cleaning Validation Expert -DS (all genders)
Randstad (Switzerland) Ltd.
Date de publication :
22 octobre 2024Taux d'activité :
100%- Lieu de travail :Aubonne
job details
For our client Merck in Aubonne, we are looking for a Cleaning Validation Expert (m/f/d) for a period of 12 months.
Your Role :
Who You Are:
Your Role :
- Coordinate cleaning validation and monitoring activities in line with the life cycle of a manufacturing process for biotech manufacturing equipment
- Establish and execute validation protocols and reports for cleaning validation
- Ensure reliability and conformity of validation and control activities in line with internal and regulatory procedures and guidelines
- Provide technical support to cleaning activities associated with the manufacturing process.
- Perform successful and on time resolution of incidents and deviations related to cleaning validation exercises (Investigates and conducts troubleshooting/root cause analysis of cleaning related incidents, deviations and cleaning out of specification results)
- Support the periodic process review and etablish documentation relation to control of the process (PCS, sampling plans and commercial panel testing )
- Lead the enhancement of cleaning practices
- Share best practices and train teams
- Be cleaning Expert during audits and inspections
Who You Are:
- Bachelor's or Master's Degree in Science, Pharmacy or Engineering.
- Minimum of 5 years of professional experiences in cleaning validation in the pharmaceutical and biotechnology industries.
- Fluent in english and french
- Proficient knowledge of cleaning validation, continuous process improvement and troubleshooting processes.
- Proficient time management skills, planning and organization capabilities.
- Proven leadership & teamwork skills, self starter, results oriented and build and maintain strong relationships with multiple groups.
- Proficient in Risk Assessment/Management Proven assessment, analytical and problem-solving skills.
- Proficient presentation skills and Technical Writing/Oral communication skills (English) Proficient in cGMP's, and FDA Regulations as it applies to pharmaceutical industry.
Kata Kulcsár
- Lausanne Professionals Life Sciences
