Regulatory Compliance Specialist

2 days ago


Oxford, Oxfordshire, United Kingdom Oxford BioMedica (UK) Limited Full time
Job Overview

We are seeking a highly skilled GMP Compliance Professional to join our Manufacturing team on a 12-month fixed-term contract. The primary objective of this role is to collaborate with our GMP Manufacturing teams to ensure timely resolution of batch-related issues and adherence to internal and external GMP requirements.

Main Responsibilities:
  • Lead investigations and root cause analysis into process and facility deviations, ensuring prompt identification and correction of issues.
  • Conduct regular self-inspections of the Manufacturing department to maintain high standards of quality and compliance.
  • Organise and facilitate individual and group training sessions regarding manufacturing SOPs and procedures to enhance employee knowledge and competence.
  • Lead updates to batch and facility documentation to capture new learnings and best practices, reflecting continuous improvement in our processes.
  • Serve as the key liaison between our QA department and the Manufacturing department, fostering effective communication and collaboration.
Requirements:
  • Proven experience working within a GMP pharmaceutical/biotechnology environment, with a deep understanding of industry regulations and guidelines.
  • Experience with manufacturing documentation, including SOPs, Deviations, Change Controls, Risk Assessments, and CAPAs, to ensure accurate record-keeping and compliance.
  • Proficiency in Microsoft Office, with the ability to effectively utilise its tools and features to support daily tasks and responsibilities.
  • Familiarity with Root Cause Analysis techniques and the capacity to amalgamate and interpret complex data in an investigative context would be an advantage.
What We Offer:
  • A highly competitive total reward package, comprising salary and benefits, designed to attract and retain top talent.
  • Wellbeing programmes to promote employee health and wellbeing.
  • Development opportunities to support career growth and professional development.
  • State-of-the-art laboratory and manufacturing facilities, providing a safe and efficient work environment.

Estimated Salary: £52,500 per annum



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