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Quality Assurance Specialist

2 months ago


Skipton, North Yorkshire, United Kingdom Dechra Pharmaceuticals PLC Full time
About Dechra Pharmaceuticals PLC

We are a global specialist in veterinary pharmaceuticals, dedicated to delivering high-quality products and services to veterinarians worldwide.

Job Title: Qualified Person

We are seeking an experienced Qualified Person to join our team at our manufacturing site in Skipton. As a Qualified Person, you will be responsible for driving the quality culture at site and divisional level, ensuring compliance with regulatory requirements and industry standards.

Main Responsibilities
  • Develop and implement quality culture initiatives across the site, collaborating with cross-functional teams.
  • Define GxP practices and standards for the site, leading gap assessments and improvement projects as required.
  • Provide quality leadership to cross-functional teams, ensuring an holistic and systemic quality approach is embedded in everything we do.
  • Escalate quality issues to the Head of Quality and SLT, ensuring timely resolution and compliance.
  • Perform QP batch certification of licensed medicines, providing QP support as required for factory issues, expert reports, and documentation.
  • Work with Group Regulatory Affairs to provide expert GMP advice on new submissions and variations/supplements.
  • Participate in internal and external audits, supporting vendor quality management activities at site and divisional level.
Requirements
  • Eligibility to perform the duties of a Qualified Person under relevant EU and US regulations.
  • Extensive experience in pharmaceutical quality departments, with in-depth knowledge of licensed products, processes, and legislation.
  • Previous experience working with regulatory agencies, such as MHRA/VMD, FDA, and participating in inspections.
  • Strong project management and time management skills, with excellent interpersonal and communication skills.
  • High levels of attention to detail, with the ability to work accurately in a busy and demanding environment.