Control Systems Validation Specialist

Thermo Fisher
Posted on

Type

Mid-level industry position

The Job We are looking for a Control Systems Validation Specialist who will be responsible for providing Computer Systems Validation expertise and support for the validation and qualification activities. The successful candidate will work as part of the Quality Team responsible for the generation,review and approval of Qualification and Validation documentation to enable compliance to Regulatory requirements. Location: Horsham Division Specific InformationWith unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivalled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labelling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standardsWhat will you do?
  • Be the Subject Matter Expert to provide regulatory guidance and support to the Quality Team on applicable regulatory matters and manage the validation lifecycle.
  • Organise and lead validation activities in order to provide an effective validation service
  • Author, review, assist with development and approve the generation and execution of compliance documentation for :
  • Risk assessments
  • User and Functional Requirement Specifications & Test Scripts
  • Change Management, reporting and issue resolution, gap analysis
  • SOPs, guidelines & processes
  • Data Integrity
  • Facilitate and support training in new compliance processes.
  • Provide support for assessment of new and existing suppliers through quality system audits and assessments to ensure compliance with regulatory requirements.
  • Maintain oversight and facilitate the timely resolution of CAPAs and Deviations with System owners and the Quality team
  • Responsible for attending meetings with external auditors, including suppliers, to respond to any IT Quality System related queries
  • Contribute to the continuous improvement of the Quality Management System processes, records and written procedures.
  • What we are looking for
    • Solid experience working within an IT compliance or computer system validation role within a regulated industry preferably Pharmaceutical.
    • A degree or equivalent in an IT field or equivalent technical discipline.
    • Working knowledge of the system/software lifecycle, IT Project Management and development of validation/qualification documentation within a regulated environment
    • Excellent written and verbal communication skills, strong presentation skills and able to communicate complexity in simple term
    Whatโ€™s in it for you?We can offer excellent opportunities to progress your career along with training and a chance to be a part of a growing successful organization

About us:As the world leader in serving science, our work is more than something that fills our days. When youโ€™re part of Thermo Fisher Scientific, youโ€™ll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world. Each one of our 70,000 extraordinary minds has a unique story to tell. Itโ€™s not just a career, itโ€™s a chance to realize your best โ€“ professionally and personally.

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About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands - Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services - we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

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Posted on

Type

Mid-level industry position

Horsham%2C%20United%20Kingdom

Horsham , United Kingdom