EXPLORE

Careers at ThermoFisher Scientific

Apply Now >>    
Job ID :
66944BR
Location :
United Kingdom - Swindon
:
Job Description

Key Responsibilities:

To maintain the qualification & validation status of processes and systems in support of new, transferred, and existing products through definition & maintenance of contemporary methodologies & standards.

  • The QA Head of Validation is the owner of Qualification and Validation of existing (operational) equipment, systems, products and processes (manufacturing, packaging and cleaning).
  • Management of the Qualification / Validation Group
  • Responsibility for the Qualification and Validation “system” and methodology
  • Responsibility for the Site Validation Master Plan
  • Responsibility for planning, coordination, execution and follow-up of qualification and validation activities
  • Accountability to the Technical Committee for periodic updates on performance against Site VMP
  • Contribution to maintaining and periodically evaluating the qualification/validation/part11 status of equipment, systems, products and processes
  • Spokesperson during internal and external audits for qualification/validation of “operational” equipment, systems, products and processes
  • Responsibility for the qualification/validation budget including costs charged to projects / clients
  • Responsibility (indirect) for Qualification of laboratory equipment
  • Close link with the functions responsible for qualification/validation of analytical methods
  • Active involvement in the introduction of new products, new processes, new equipment and new systems

EH&S:

  • Understand and ensure implementation of emergency procedures and safe systems of work.
  • Ensure compliance with environment, health and safety rules, signage and instructions at all times.
  • Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

Qualifications/Experience:

  • Science based degree
  • Working knowledge of the principles and guidelines for GMP as set out in the ‘Orange Guide.’
  • Professional background in a Pharmaceutical Production environment (e.g. Production, Product Introduction, Engineering, Quality Assurance)
  • Knowledge of typical pharmaceutical production processes, equipment and systems which are used for these processes, and the environment in which these processes run
  • Knowledge of the concepts, legislation, guidelines and requirements related to qualification and validation of products, processes, equipment and systems, including Computer System Validation and Part11
  • Knowledge of GMP requirements and pharmaceutical legislation - compliance-driven
  • Capable of leading cross-functional teams and motivating people
  • Good communication and collaboration skills


Apply Now >>    
Link for schema
Join our Talent Community

If you're ready to make a difference in the world, you can do it here.

Join

SHARE

5 Reasons to Work at Thermo Fisher Scientific
View
Search Jobs by Map
Search