Qualified Person
Qualified Person
United Kingdom, London
Permanent
22 March 2023
- Main duties would be to ensure that all Quality and Compliance requirements are met for Customers, Suppliers, Internal Departments and Regulating Agencies in accordance with applicable EU regulations.
- Management of various quality parameters, such as; Complaints, Deviations & CAPA, Audits, Quality Metrics, SOPs, Change control, Specifications, Manufacturing Documentation Approval and Training and Batch Certifications.
- To provide QP GMP declarations including on site audits if required.
- Review study and lot specific documentation necessary to facilitate QP Release. Use technical knowledge to assess the criticality of any issues.
- Liaising with the Regulatory Authorities.
- Provide support for resolution of technical problems involving existing global supply products
- Actively encourage input/development of QMS, Site Quality/EHS Councils and Continuous process improvement.
- Experience in auditing suppliers, consultants, API facilities, and drug product manufacturing or testing sites.
- Should be eligible Qualified Person with experience in undertaking the routine duties of a Qualified Person and in a Quality related role within the pharmaceutical industry.Background and skills
- Relevant University Qualification in the chosen area of expertise
- Minimum of 2 years pharmaceutical experience or associated manufacturing industry experience.
- Knowledge in sterile, solid and liquid dosage forms.
- Broad knowledge of pharmaceutical manufacturing processes.
- Good inter-personal skills and presentation skills.
- Location: UK or Europe
- Fluent in English or any other European languages
