QC Technical Writer
Thermo Fisher Scientific
Swindon, United Kingdom
6d ago

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 $35 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.

As a QC Technical Writer, you will provide GMP compliance support for the QC laboratory. This will include support with deviations, OOS investigations, CAPAs and change controls, maintenance of departmental KPIs and involvement with other projects to support Data Integrity, automated systems and improve the performance and culture within the department.

What will I do?

  • Provide technical support in writing and updating :
  • Deviation investigations.
  • OOS, OOT and Unexpected result investigations.
  • CAPAs
  • SOPs / Work Instructions.
  • Analytical methods and specifications.
  • Relevant department specific Change Controls and present to committee.
  • Maintain departmental KPI matrix.
  • Support GMP and Data Integrity compliance in the QC laboratory.
  • Facilitate and support initiatives to improve compliance performance and culture within the department.
  • Always maintain required housekeeping standards.
  • Support the implementation and use of automated systems such as LIMS, TrackWise etc
  • To be flexible and adaptable in supporting all aspects of the QC laboratory when required.
  • To carry out any other tasks which may be required from time to time.
  • To comply with GMP requirements and company rules, policies and procedures.
  • EH&S

  • 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.
  • What do I need?

  • Science or Engineering based degree (desirable).
  • Knowledge of the principles and guidelines for GMP.
  • Substantial experience working in pharmaceutical manufacturing, with experience of QC activities.
  • Understanding of the end to end manufacturing process.
  • Proactive approach to work, with a willingness to do what needs to be done to deliver against milestones.
  • Pragmatic / common sense approach to problem solving.
  • Demonstrable ability to make sound risk based decisions.
  • Experience in lean / removal of non-value added activities from documentation and processes (desirable).
  • Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.

    Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.

    Our global team of more than 90,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

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