Qualified Person

Additional Information

Location: High Wycombe

Salary: Circa £75,000 + Bonus + Benefits

Job Type: Permanent

Job purpose

To carry out batch review and QP certification for the 3^rd Party products for solid dose and non-sterile liquids. In addition, the role requires auditing of manufacturing sites and API manufacturers as required.

Main Responsibilities and Duties

• To undertake the duties of a Qualified Person as defined in Article 51 of 2001/83/EC for products manufactured and/or packed at CMOs
• To ensure the requirements of FMD are in place ahead of batch release for 3^rd Party products and perform the necessary actions to manage serialisation requirements
• To assist the vendor management program by performing GMP and GDP audits of CMOs and other vendors as appropriate in line with current regulations
• Ensure the timely response to audit findings at CMOs and other vendors. Track actions via the CAPA system and manage through to closure
• Ensure quality support to business partners through involvement with training, non-conformance investigation and reporting, and overall coaching/mentoring of business partners in quality matters
• Ensure the Quality Technical agreements and Distribution agreements are tracked and updated as required to maintain compliance
• To ensure that all changes are recorded via the change control system then managed appropriately to closure including changes to API DMF or CEPs
• Review and approve CMO documentation such as batch records as required
• To input into the monthly KPI slide deck with relevant information
• To create or update SOPs for the 3^rd Party Team as required
• Ensure adherence to agreed SOPs
• To participate positively in reviews to improve effectiveness and efficiency
• To work within multidisciplinary project teams as required by the business
• To undertake other tasks required for which training has been provided

Experience and Qualifications

• Eligible to act as a QP as defined in EU Directive 2001/83/EC
• Lead auditor qualification and significant experience of auditing pharmaceutical manufacturing facilities
• Experience in a range of commercial manufacturing environments ideally including sterile manufacture, solid dose and oral liquids
• A deep understanding of Good Manufacturing Practices in addition to ICH and ISO requirements applicable to the dosage form
• Good understanding and experience of Pharmaceutical Quality Management Systems in line with ICH Q10 requirements
• Excellent communications and interpersonal skills
• Organised and good at working with detail in a logical and methodical way
• Well-developed IT skills