CQV Consultant - Basel, Schweiz - headcount AG

Beschreibung

• Lead and support CQV activities for equipment, utilities, and facilities in compliance with regulatory requirements, including FAT, SAT, IQ, OQ, and PQ.
• Develop and execute validation protocols, including cleaning validation protocols, and ensure adherence to approved procedures and timelines.
• Perform risk assessments and identify critical parameters for validation studies, ensuring product quality and patient safety.

• Manage CSV activities for critical systems used in manufacturing, ensuring compliance with regulatory guidelines such as 21 CFR Part 11.
• Develop and execute CSV protocols and test scripts for software applications, including data integrity assessments and validation of automated processes.
• Collaborate with IT and engineering teams to ensure CSV activities are integrated into system development life cycle processes.

• Review and approve validation documentation, including protocols, reports, and standard operating procedures (SOPs), to ensure completeness and compliance with regulatory standards.
• Maintain documentation in accordance with Good Documentation Practices (GDP) and ensure traceability of validation activities.
• Support regulatory inspections and audits by providing documentation and responding to inquiries related to CQV and CSV activities.

• Work closely with manufacturing, engineering, quality control, and regulatory affairs teams to address quality issues, deviations, and CAPAs related to CQV and CSV.
• Provide technical expertise and guidance to ensure effective problem-solving and continuous improvement in quality systems and processes.
• CAPEX & Scale-up project experience beneficial
• Languages: German required