As a Qualified Person at Thermo Fisher Scientific, you will ensure compliance with GMP and regulatory standards, handle batch certification, and lead quality management initiatives.
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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.
- 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 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".
- 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.
Top Skills
Gmp
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