Quality Assurance Officer

Milton, England, gb
Company: Thermo Fisher Scientific
Category: Management Occupations
Published on 2021-06-16 06:03:50

Job Title Quality Assurance Officer
Req ID: 148591BR

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. 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.

How will you make an impact?
To support all quality related activities for the site, to active manage and implement GMP awareness and promote the use of quality tools at Milton park. To review and manage all site related GMP documentation

What will you do?

  • Review all GMP PDS documentation for accuracy and compliance with site procedures and corporate standards.

  • Support the internal audit as the schedule dictates and maintain an inspection ready status. And hosting and participation in client, Regulatory and supplier audits.

  • To manage the BMR generation and release processes in a pro-active manner (i.e. issuing of BMRs, issuing and approval of labels, reconciliations, material certifications etc) and support the post-execution BMR responses to clients

  • To support the supplier assurance program including the approval of suppliers and auditing.

  • To perform initial quality reviews and approvals of Deviations, qualification documents, OOS, change controls and SOPs.

  • Generation, issue and archive of non-project documents, including log books and laboratory notebooks.

  • To support material and finish product release activities.

  • To work in compliance with Company and Regulatory requirements.

  • To provide quality support to other department and activities, by maintaining knowledge of site policies and procedures, especially the quality systems.

  • Satisfactorily complete all cGMP and safety training in conformance with departmental and site requirements and timelines

  • Generation of site quality matrix such as change controls, Overdue SOP reviews, Overdue CAPAs, Overdue Change controls.

  • Understand emergency procedures and comply with 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.

  • How will you get here?

  • Science or pharma graduate, or equivalent experience.

  • 3 years’ experience in GMP and the requirements of the pharmaceutical development industry.

  • Excellent use of Microsoft office applications (Word, Excel, etc.).

  • Desirable – experience of SAP and Trackwise systems.

  • Good working knowledge of cGMP and the ability to follow procedures.

  • Excellent interpersonal and communication skills (both oral and written)

  • Ability to work in matrix teams and without supervision

  • Well motivated with the capacity to work under pressure and a flexible attitude towards work

  • Ability to liaise with other staff and clients at all levels in a confident manner

  • Thoroughness and attention to detail

  • At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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