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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



Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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