Senior Quality Assurance Specialist

7 days ago

Edinburgh, Edinburgh, United Kingdom SRG Full time
About the Role

SRG is seeking an experienced Qualified Person to join their team in a permanent role with excellent salary and benefits.

This is a fantastic opportunity for a seasoned professional to take on a challenging position with a dynamic company.

Key Responsibilities
  • Regulatory Compliance: Undertake the duties of a Qualified Person as defined in Directive 2001/83/EC and Directive 2001/82/EC.
  • Quality Assurance: Influence the quality agenda and support the maintenance of the Quality Management System (QMS) to ensure it complies with all relevant legislative requirements.
  • QP Function: Provide a Qualified Person function for licensed Advanced Therapy Medicinal Products (ATMPs) according to the relevant directives and guidelines.
  • Batch Review and Release: Conduct QP review of executed batch manufacturing records and certify as defined under SI2012/1916 and under the terms of the Company's Manufacturing Investigational Authorization (MIA) and Manufacturing Investigational Authorization (IMP) and relevant regulatory filings (Marketing Authorization, Investigational New Drug, and Investigational Medicinal Product Dossier as applicable).
  • Quality Management Systems: Support the process of batch review and release and coordinate with Quality peers performing batch review duties as necessary.
  • GMP Compliance: 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.
  • Quality Management Systems Implementation: Review and implement Quality Management Systems in compliance with current GMP and any regulatory updates or observations.
  • Product Quality and Release: Maintain product quality and release by enforcing quality assurance policies and procedures and GMP requirements.
  • Subject Matter Expert: Act as a Subject Matter Expert (SME) to facilitate site compliance with the company's Quality Management Systems.
  • Quality Assurance Support: Support the Quality Assurance department for all compliance inspections of the site, including internal audits and regulatory inspections.
  • Professional Development: Maintain knowledge of current guidelines and regulatory advancements in line with the role for continued professional development.
  • Quality SOPs: Write, review, approve, and maintain Quality Standard Operating Procedures (SOPs) applicable to key areas of the Pharmaceutical Quality System (PQS) as required.
About You
  • Eligibility: Eligible to undertake the duties of a Qualified Person as defined in Directive 2001/83/EC and Directive 2001/82/EC.
  • Education: A relevant degree qualification (preferably in Chemistry, Pharmacy, or Biological Science).
  • Regulatory Experience: Experience with FDA, MHRA, EMA, and other regulatory agencies.
  • Quality Assurance Experience: Previous Quality Assurance experience.
  • Pharmaceutical Manufacturing Experience: Prior experience in a pharmaceutical manufacturing environment.
  • Communication and Leadership Skills: Excellent communication and leadership skills.

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