Qualified Person

Role: 3-5 days dependant on availability – Fixed Term Contract for initial 6 months

The following activities will be performed thereby ensuring Product Quality, GMP and patient safety is maintained to an appropriate standard for the products supplied to the market and regulatory compliance commitments are met:

• Responsible for supporting the Associate Director Quality to ensure the effective day to day management/maintenance of key elements of the PQS
• Site Change Controls
• Supporting the Product Quality Review process for BST manufactured products
• Assessment and approval of Validation/qualification activities and management of the Site Validation Master plan
• Investigation of anomalies to assess impact on product quality, identify root cause and establish CAPAs
• Maintain compliance of and introduction of new APIs, raw materials and packaging components
• Able to act as supporting host during customer, regulatory and corporate audits
• Able to provide training in all aspects of Pharmaceutical Quality System and GMP including procedural updates
• Providing support and advice during cross functional investigations/projects as required
• Generation, review and approval of validation and other technical documents
• The review and approval of master batch manufacturing / packaging records
• Able to conduct internal and external audits as appropriate
• Supporting the technical transfer new products
• Deputise for the Associate Director Quality ensuring that all services are maintained to maximise operational effectiveness and efficiency so that both regulatory and business requirements are met at all times
• Working with the other Qualified Persons to continually improve the PQS in accordance with UK/EU and corporate requirements
• To work with other departments/functions to ensure a strong QA culture throughout the business
• To perform the Qualified Person duties in accordance with UK and EU requirements

• Member of either Royal Pharmaceutical Society, Royal Society of Biology or Royal Society of Chemistry
• Eligible to act as a Qualified person (QP) on MIA, MIA(IMP) and ManA once granted, eligible to certify batches in line with UK Statutory Instruments
• Detailed understanding and significant practical experience of UK and EU GMDP for human and veterinary medicines, medical devices and other product types (e.g. Cosmetics, Food supplements, etc) across multiple dosage forms
• Extensive experience of working in a Quality Assurance related role in the Pharmaceutical Industry
• Knowledge of UK and EU quality related pharmaceutical regulations, guidance and standards
• Experience of conducting quality based investigations and root cause analysis
• Experience of conducting self-inspections and external audits of contract manufacturers/packers and service providers
• Decisive thinker able to work within agreed timescales
• Previous experience of leading/managing teams
• Experience of US pharmaceutical regulations would be an advantage