Quality Assurance Specialist

5 days ago

Nottingham, United Kingdom CHR Life Sciences Full time
Job Summary

We are seeking a highly skilled Sterility Assurance Specialist to join our Quality Assurance team at CHR Life Sciences. As a key member of our team, you will be responsible for ensuring the highest level of sterility assurance and environmental monitoring in our compounding unit.

Key Responsibilities
  • Regulatory Compliance: Maintain an appropriate level of regulatory compliance to protect the end users of our products.
  • Quality Management System: Design, implement, monitor, and maintain the quality management system to ensure effective sterility assurance and environmental monitoring.
  • License Management: Manage licenses related to special manufacture and participate in Competent Authority inspections and customer audits.
  • Team Management: Manage the QA team to deliver its objectives and provide coaching and mentoring to other functions in problem-solving.
  • Investigations: Support and lead problem-solving investigations for product and process deviations or customer complaints.
  • Technical Support: Provide technical support in interpretation of microbial identification and environmental monitoring data, and participate in compounding complaints investigation, nonconformance, and quality incidents investigation.
  • Reporting: Responsible for tracking and reporting quality metrics for internal and external use.
  • Validation: Carry out validation and experimental design in association with EMEA Sterility Assurance Manager.
  • External Lab Oversight: Qualification, auditing, and monitoring the service levels of external labs, providing proper oversight on technical aspects.
  • Documentation: Support the development of quality documentation, including SOPs.
  • Training: Providing microbiological training and aseptic operator training for operational and quality staff.
Requirements
  • Experience: 3 years' experience in implementing environmental control programs and OOL investigation and correction, preferably in an aseptic manufacturing background.
  • Education: Degree in Microbiology, although others may be considered with relevant experience.

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