Qualified Person
£100000 - £120000 per annum
England

Job Title: Qualified Person (QP) - Pharmaceutical Manufacturing

Location: South East, UK

SciPro is excited to partner with a pioneering pharmaceutical company in the South East seeking a Qualified Person (QP) to support batch certification and lead Quality Assurance at their manufacturing site.

This company is renowned for developing and producing innovative medicines essential for treating patients across the UK. As a Qualified Person, you will collaborate with the Head of Quality, other QPs, and Site Management to ensure both Local and Global Quality Systems operate in compliance with GMP standards.

Main Responsibilities:

  • Perform the duties of a Qualified Person with expertise in terminal sterilisation and aseptic manufacturing methods.
  • Review and evaluate batch records, performing batch certification and release in line with Good Manufacturing Practice (GMP) and Marketing Authorisation/Clinical Trial Authorisation requirements.
  • Collaborate with the Head of Quality and other QPs to maintain and enhance the Global Quality System.
  • Review and approve deviations, complaints, CAPAs, change controls, and out-of-specification investigations.
  • Mentor and coach site teams on Quality and Continual Improvements.
  • Train site staff in Quality Management System (QMS) requirements.
  • Develop and maintain effective working relationships with all site staff, QPs, and regulatory inspectors.

Qualifications/Experience:

  • Eligibility to be nominated as a Qualified Person under EU Directive 2001/83/EC (Medicinal Products for Human Use).
  • Extensive experience in a pharmaceutical manufacturing environment, ideally with sterile products.
  • Strong understanding and application of GMP and regulatory requirements.
  • Proven experience in line and performance management within QA/QC.
  • Familiarity with batch certification and release processes.
  • Experience in handling and resolving deviations, complaints, CAPAs, change controls, and out-of-specification investigations.
  • Demonstrated ability to coach, mentor, and train staff in quality principles and practices.
  • Excellent communication and interpersonal skills to liaise effectively with site staff, QPs, and regulatory bodies.
  • Strong analytical and problem-solving skills.
  • Ability to work collaboratively in a team environment while maintaining a high degree of attention to detail.
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