Qualified Person

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

• Job Description :

  As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
  
  DESCRIPTION:
  Join our quality team at Thermo Fisher Scientific, where you'll make a meaningful impact ensuring product quality and regulatory compliance across our pharmaceutical and scientific operations. As a Senior Quality Specialist, you'll provide technical leadership and oversight for GMP manufacturing environments, working cross-functionally to drive quality excellence and continuous improvement. You'll serve as a subject matter expert, conducting risk assessments, leading investigations, managing CAPAs, and ensuring adherence to global regulatory requirements. This role offers the opportunity to directly contribute to our mission of enabling customers to make the world healthier, cleaner and safer through robust quality systems and processes.

  Position Summary:

  Join our ambitious team at Thermo Fisher Scientific Inc. and take on a pivotal role within our world-class manufacturing department! As a Qualified Person, you will be instrumental in ensuring the flawless execution of our operations at Patheon UK, driving outstanding quality and compliance.

  Responsibilities:

  • Qualified Person (QP) responsibilities, duties, batch certification, and disposition as defined in 2001/83/EC, 2001/82/EC, 2011/62/EU, and Eudralex Volume 4, Annex 16. Ensure adherence to relevant cGMPs for products released to the US market.
  • Ensure that products are manufactured in strict accordance with GMP, site procedures, and applicable regulatory requirements.
  • Stay in sync with international regulatory guidance, corporate, and client requirements. Ensure all site work aligns with these standards.
  • Continuously upgrade technical and professional competence, ensuring complete understanding of any new product or process before conducting QP batch certification and disposition.
  • Conduct regular audits, self-inspections, and spot checks.
  • Support investigations, root cause analysis, and approve Major/Critical deviations, complaints, and change proposals with process/product impact.
  • Support the QMR process and the implementation of Operational Excellence by encouraging peers and collaborators to identify and implement improvements.
  • Act as change agents, driving balanced improvements to work processes.
  • Proactively ensure continuous improvement of the QMS, maintaining it in an inspection-ready state.
  • Drive and react to system trending (e.g., deviations, complaints, and environmental management) ensuring ongoing quality performance and improvements.
  • Establish and maintain effective communication with clients to align internal and external expectations.

  EHS:

  • Implement emergency procedures and safe systems of work.
  • Ensure compliance with environment, health, and safety rules at all times.
  • Promptly report and investigate all accidents, near misses, and breaches of rules.

  
  Minimum Requirements/Qualifications:

  • Minimum Degree in Chemistry, Pharmacy, or Microbiology.
  • Minimum 3 years of experience completing 'Qualified Person' responsibilities as outlined in 2001/83/EC and 2001/82/EC (as amended).
  • Substantial experience in a pharmaceutical quality function within a sterile manufacturing site.
  • Up-to-date knowledge of GMP guidelines (UK "Orange Guide", EU "Eudralex Volume 4", U.S. "CFRs" and other relevant regulations).
  • Excellent scientific and technical knowledge.
  • Not on the "FDA DEBARMENT LIST".

  
  Key Skills:

  • Capable of working to deadlines and prioritizing multiple tasks.
  • Excellent written and verbal communication skills.
  • Flexibility to meet changing business needs and priorities.
  • Pragmatic, well-organized with a logical and methodical approach.
  • Leadership experience with the strength of character to guide cross-functional teams.
  • Demonstrated project management and organizational capabilities
  • Strong analytical and problem-solving skills
  • Experience hosting regulatory inspections and customer audits preferred
  • Customer-focused mindset with strong attention to detail