CQV Consultant

vor 2 Monaten

Basel, Schweiz headcount AG Vollzeit
CQV Consultant

As CQV you will ensure the quality and compliance of our clients manufacturing processes. Collaborating closely with cross-functional teams to execute CQV and CSV activities, with a particular emphasis on cleaning validation and CSV for critical systems.

Key Responsibilities:

Commissioning, Qualification, and Validation (CQV):
  • 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.
Computer System Validation (CSV):
  • 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.
Documentation and Compliance:
  • 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.
Cross-Functional Collaboration:
  • 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
Please apply directly online with your CV.

**Please only apply if you are eligible to work in Switzerland and the EU**

headcount AG

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