Qualified Person

Work Schedule

Environmental Conditions

Job Description

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:

• Complete 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.
• Provide backup for other QPs on site.

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.