Qualified Person
Qualified Person
Posted on :
23-08-2025
Employer Active
1 Vacancy
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Job Description
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.
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.
Employment Type
Full-Time
Key Skills
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