Qualified Person

2 weeks ago

Skipton North Yorkshire, United Kingdom Dechra Pharmaceuticals PLC Full time

Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
The role also offers a great flexible work policy.
Based out of our manufacturing site in Skipton, we are recruiting for an experienced Qualified Person to join our growing Dechra family. The Skipton manufacturing site manufacturers a variety of dosage forms including medically necessary animal drugs for the US, UK, Europe and other markets. Reporting to the Head of Quality, the successful candidate will drive the quality culture at site and at the divisional level in addition to batch certification activities.
Driving the transformational quality culture initiatives across the site across the site by liaising with cross functional teams.
Through active engagement with the divisional Quality team and external stakeholder groups, define GxP practices and standards for the site and lead gap assessments and improvement projects as required.
Provide Quality leadership to cross-functional teams working on FMEA, root cause analysis, and other investigative tools to ensure an holistic and systemic quality approach is imbedded in everything we do.
Escalate to the Head of Quality and SLT any trends and quality issues that are detected during batch review, systemic in nature or observed in operations.
Performing QP batch certification of licensed medicines (per applicable regulations) and providing QP support as required for factory issues, expert reports, annual product reviews and documentation to support license applications/variations and product release.
Work with Group Regulatory Affairs by providing expert GMP advice regarding new submissions and variations / supplements.
Participating in internal and external audits, and support vendor quality management activities both at site and divisional level.
Provide leadership and participate in internal and external, and other regulatory agency inspections (UK, US, EU,etc.)
Eligibility to perform the duties of a Qualified Person under the provision of Directive 2001/83/EC, Directive 2001/82/EC, Directive 2001/20/EC and Statutory Instruments (SI) 2012 1916, SI 2004 1031 and SI 2013 2033.
Extensive experience in Pharmaceutical quality department.
Previous experience working with MHRA/VMD, FDA and participating in regulatory agency inspections.
Strong project management and time management skills.
Excellent knowledge of global pharmaceutical legislation.

  • Qualified Person

    Found in: Talent UK C2 - 2 weeks ago

    Skipton, United Kingdom Dechra Full time

    Job Introduction Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals. Dechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide. ...

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