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Regulatory Affairs Compliance Coordinator

2 months ago

London, Greater London, United Kingdom S3 Science Full time £30,000 - £40,000
Position Overview:

We are seeking a dedicated Regulatory Affairs Compliance Coordinator to join our team at S3 Science, a pioneering organization in the biotech sector focused on innovative technologies for gene expression control.

Key Responsibilities:
  • Ensure that documentation is maintained in accordance with established protocols.
  • Provide training and support as necessary, while regularly updating training materials.
  • Handle daily administrative duties, including user management and document assistance during audits by regulatory bodies and third parties.

Specific Duties:
  • Serve as the subject matter expert (SME) for designated processes and systems within Quality Assurance Document Control, including training, document archiving, retention, and reconciliation.
  • Generate Key Performance Indicator Reports for various departments as needed.
  • Ensure compliance with Good Manufacturing Practices (GMP), Data Integrity, and Good Documentation Practices (GDP) in all tasks performed.

Additional Responsibilities:
  • Address issues, Corrective and Preventive Actions (CAPAs), Change Controls, Batch Manufacturing Records (BMRs), and audit/inspection actions in a timely and effective manner.

Qualifications:
  • Proficient in computer applications, particularly Microsoft Excel, Word, and PowerPoint, with the ability to adapt to new software and web applications.
  • Experience with electronic Quality Management Systems is preferred.