Qualified Person at Thermo Fisher Scientific

Swindon, England, United Kingdom

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Life SciencesIndustries

Requirements

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

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

Skills

GMP

cGMP

Batch Certification

Batch Disposition

Audits

Self-Inspections

Root Cause Analysis

Deviations

Change Control

QMS

Regulatory Compliance

EudraLex Volume 4

Annex 16

QMR

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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