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Qualified Person - QP

Harris Lord Recruitment
Job LocationStoke-on-Trent
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Position: Qualified Person (QP)Location: Stoke-on-TrentA leading biotechnology business, biopharmaceutical manufacturing products and services and specialists in a niche areas are currently looking to recruit a Qualified Person (QP) to join the team near Stoke-on-Trent.The QP will be accountable for:- Review of manufacture and testing documentationThe QP will be responsible for:- Ensuring timely placement of GMP batches and acting as Subject Matter Expert- Facilitate site compliance with the Companys Pharmaceutical Quality System Duties

  • To be named on the Manufacturing Licence(s) and have responsibility for ensuring that the respective regulatory requirements for batch release are met.
  • Perform QP duties in accordance with Directives 2001/83/EC, 2003/94/EC, 2001/20/EC, and Eudralex Volume 4, part I, II and III including relevant annexes.
  • Support internal and external queries relating to QP responsibilities and batch disposition.
  • Apply GMP regulations consistently, using quality and compliance knowledge to mentor others
  • Utilise knowledge for continuous improvement activities.
Requirements:- Educated to degree level or equivalent in Chemistry, Biology or Pharmacy- Have extensive experience as a QP- Biopharma/ Biotech (ideal)- Sterile products (required)- Pharma- QP eligibility and associated memberships- External Lead Auditor status (ideal)- Developing, mentoring and training a site Quality culture, supporting Quality and Operations leaders with GMP compliance and batch release decision-making- Strong written and verbal communication skills are essentialA competitive package is on offer.Keywords:Qualified Person, QP, Quality Assurance, QA, Biopharma, Biologics, Sterile, Sterility, GMP, Batches, eQMS

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