Quality Assurance Specialist

☞ Thermo Fisher Scientific

View: 109

Update day: 01-06-2024

Location: Northampton East Midlands

Category: Quality Assurance / Quality Control

Industry: Biotechnology Research Pharmaceutical Manufacturing

Job type: Full-time

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Job content

Job Responsibilities
  • Provide QA oversight to operational activities taking place within the site.
  • Review all GMP PDS documentation for accuracy and compliance with site procedures and corporate standards.
  • Review of logbooks & support area controls.
  • Online review and Closure of batch records
  • Review and update of Standard Operating Procedures and Controlled Documents as required.
  • Proactive generation and timely investigation/review of minor DRs & CAPA in conjunction with other QA personnel
  • To perform review of qualification documents and OOS.
  • Support the internal audit as the schedule dictates and maintain an inspection ready status. And hosting and participation in client, Regulatory and supplier audits.
  • Training/coaching of Operations staff & QA peers.
  • Communicate effectively, attending Tier 1 meetings and participate in planning, RAPID meetings and problem solving 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.
  • Support the QMS by generating of site quality matrix such as change controls, Overdue SOP reviews, Overdue CAPAs, Overdue Change controls
  • Support the overview of the QMS health status eg deviation trend analysis.
What education/experience will you bring?
  • Experience working within a pharmaceutical quality function
  • Significant experience working within equipment/facility validation
  • Working knowledge of the principles and guidelines for cGMP as set out in the ‘Orange Guide’ and a robust understanding of an effective Pharmaceutical Quality System.
  • Relevant science based degree; e.g. Chemistry, Biology, Pharmacy preferred.
  • Excellent interpersonal skills with the ability to appropriately challenge behaviours at all levels of the organization.
  • Excellent report writing skills.
  • Good time management.
  • Proactive approach to continuous improvement and project work with a willingness to do what needs to be done to deliver the project milestones.
  • Proven experience in problem solving is essential, with experience in the investigation of quality incidents, Human Factors and effective CAPA.
  • Demonstrable ability to make risk based decisions, apply Quality Risk Management principles and escalate at the appropriate level.
  • Ability to perform internal audits.
  • Front line QA for regulatory and customer audits.
Benefits We OfferAs well as a salary reflective of your experience, you’ll also receive a company bonus, private medical insurance, life assurance, contributory pension, 25 days holiday (plus bank holidays) with the option to tailor additional benefits to suit you such as additional health plans, holiday purchase scheme, stock purchase scheme, GymFlex and more!!About UsWhen you are part of Thermo Fisher Scientific, you will do meaningful work, and be part of a team that values performance, quality and innovation. As a member of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $40 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.
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Deadline: 16-07-2024

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