- Cleaning Validation Strategy, develop and implement Cleaning Validation strategies and procedures in alignment with regulatory requirements, including FDA and EMA guidelines.
- Protocol Development and Execution, lead the development, review, and approval of Cleaning Validation protocols, including the determination of worst-case scenarios and appropriate analytical methods. Execute Cleaning Validation studies, including swab and rinse sampling, to demonstrate the effectiveness of cleaning processes and removal of residues.
- Risk Assessment and Mitigation, conduct risk assessments to identify critical cleaning parameters, potential sources of contamination, and mitigation strategies to ensure product quality and patient safety.
- Documentation and Compliance, prepare and maintain comprehensive documentation of Cleaning Validation activities, including protocols, reports, and standard operating procedures (SOPs). Review and approve Cleaning Validation documentation generated by other team members or external contractors to ensure accuracy and completeness.
- CAPEX & Scale-up project experience beneficial
- Languages: German required
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Cleaning Validation Consultant - Basel, Schweiz - headcount AG
Beschreibung
Cleaning Validation ConsultantAs a Cleaning Validation Consultant, you will be responsible for ensuring the effectiveness and compliance of our clients cleaning processes across new manufacturing facilities. You will support and execute Cleaning Validation activities in accordance with regulatory standards and internal procedures.
Key Responsibilities:
**Please only apply if you are eligible to work in Switzerland and the EU**
headcount AG
