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Regulatory Compliance Expert

2 months ago

Edinburgh, Edinburgh, United Kingdom SRG Full time

Job Summary

SRG is seeking an experienced Qualified Person to join their team at an exciting time for the business as they continue to expand their operations.

This is a fantastic opportunity for an experienced Qualified Person to take on a permanent role with excellent salary and benefits.

The Role:

  • Undertake the duties of a Qualified Person as defined in Directive 2001/83/EC and Directive 2001/82/EC, ensuring compliance with all relevant legislative requirements.
  • Influence the quality agenda and support the maintenance of the Quality Management System (QMS) to ensure it meets all regulatory standards.
  • Provide a Qualified Person function for licensed Advanced Therapy Medicinal Products (ATMPs) according to the relevant directives and guidelines.
  • Conduct Qualified Person review of executed batch manufacturing records and certify as defined under SI2012/1916 and under the terms of the Company's Manufacturing Authorization and relevant regulatory filings.
  • Support the process of batch review and release and coordinate with Quality peers performing batch review duties as necessary.
  • Work with the Head of Quality and fellow Qualified Persons to ensure that Good Manufacturing Practice (GMP) compliance is implemented and maintained in accordance with the appropriate legislation, company policies/procedures, and manufacturing authorizations.
  • Review and implement Quality Management Systems in compliance with current GMP and any regulatory updates or observations.
  • Maintain product quality and release by enforcing quality assurance policies and procedures and GMP requirements.
  • Act as a Subject Matter Expert (SME) to facilitate site compliance with the company's Quality Management Systems.
  • Support the Quality Assurance department for all compliance inspections of the site, including internal audits and regulatory inspections.
  • Maintain knowledge of current guidelines and regulatory advancements in line with the role for continued professional development.
  • Write, review, approve, and maintain Quality Standard Operating Procedures (SOPs) applicable to key areas of the Pharmaceutical Quality System (PQS) as required.

The Person:

  • Eligible to undertake the duties of a Qualified Person as defined in Directive 2001/83/EC and Directive 2001/82/EC.
  • A relevant degree qualification (preferably in Chemistry, Pharmacy, or Biological Science).
  • Experience with FDA, MHRA, EMA, and other regulatory agencies.
  • Previous Quality Assurance experience.
  • Prior experience in a pharmaceutical manufacturing environment.
  • Excellent communication and leadership skills.