Qualified Person QP
Qualified Person QP
Who are Dechra?
Dechra is an international specialist veterinary pharmaceuticals and related products business. Our expertise is in the development, manufacture and sales and marketing of high quality products exclusively for veterinarians worldwide.
With offices across 24 countries in Europe and North America, we export to over 50 countries worldwide and have six manufacturing sites.
Where is the role based?
Skipton, North Yorkshire
The Dechra group employ over one thousand people. Revenue in 2018 reached £407.1m
To provide a QP service, including batch certification, in line with the QP Code of Conduct and EU GMP requirements
To support the quality improvement agenda for Dechra Skipton ensuring customer and regulatory requirements are met for all product types and markets.
Work with the other Dechra Skipton Teams to support customer challenges, always providing an effective solution to our customer’s problems every time.
The Qualified Person has responsibility for the following:
- Perform QP release of licensed medicines (as required) under the provision of Directive 2001/83/EC, Directive 2001/82/EC & Directive 2001/20/EC, SI 2012 1916, SI 2004 1031, SI 2013 2033 and provide QP support as required for factory issues, expert reports, annual product reviews and documentation to support license applications/variations and product release e.g. GMP declarations.
- To drive a quality improvement agenda to improve compliance and reduce quality issues, reworks and batch failures. To promote quality culture across the site by liaising with cross functional teams
- To define quality standards of manufacture, pack and GMP at all times to those expected and required by the business and our customers.
- To participate in internal and external audits, and support vendor quality management activities
- To ensure all factory documentation is compliant with customer and regulatory requirements.
- To ensure cGMP is maintained in the Dechra Skipton site and anticipate and develop plans for the implementation of legislative changes to QMS , systems, processes and procedures, including support for GMP training on site. Support and chair, as required, key meetings e.g. change control and deviations.
- To ensure all product licences are stored and maintained to ensure product compliance through supporting licence compliance reviews / recommendations to MA holder / releasing QP’s
- To provide guidance for higher level decisions required for change management and deviation investigations
- To provide support and participate in internal and external, and other regulatory agency inspections (MHRA, FDA, EMA, etc.)
- To assist the QA with the planning of required internal annual audits and other audits as needed and assigned
- Support Supplier Assurance programme including external audits of suppliers to provide assurance that all materials are sourced from approved suppliers
- To supply feedback to the Head of Quality and SLT on any trends and serious quality issues or non-compliances that are detected during batch review or observed in operations
- Leading the QP meetings and establishing quarterly update sessions, reviewing changes in legislation to support trainee QP’s
- Always respond to customer requests in a positive can do manner, delivering customer solutions every time within agreed timescales