Qualified Person |Negotiable
Pharma & Science
South East

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 3rd 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 3rd 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 3rd 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

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