QC Technical Writer

☞ Thermo Fisher Scientific

View: 108

Update day: 30-04-2024

Location: Swindon South West

Category: Marketing / PR Printing / Publishing

Industry: Biotechnology Research Pharmaceutical Manufacturing

Job type: Full-time

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Job content

Business Job Title: QC Technical WriterJob Profile Title: (Internal title) Lead QC TechnicianDirect Report To: Team Leader / Section HeadGroup/ Division: PSGCareer Band: 04Career Track: ProfessionalPosition Location: SwindonNumber of Direct Reports: 0When you’re part of Thermo Fisher Scientific, you’ll do exciting work, and a member 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 $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world!Position Summary:To provide GMP compliance support and expertise for the QC laboratory. This will include completing and supporting various forms of investigations, and explaining them to review boards. As a team we maintain departmental critical metrics and have involvement with other projects to support Data Integrity, automated systems and improve the performance and quality culture within the department.Responsibilities:
  • Provide technical support in writing and updating:
  • Deviation, OOS, OOT, unexpected results investigations; CAPAs; SOPs and work instructions; Analytical methods and specifications; Change controls.
  • Maintain departmental KPI matrix, support GMP and Data Integrity compliance for QC.
  • Facilitate and support initiatives to improve compliance performance and culture
  • Support the implementation and use of automated systems such as LIMS, TrackWise etc
  • To be flexible and adaptable in supporting all aspects of the laboratory, and carrying out other tasks if and when required.
  • To follow GMP requirements and company rules, policies and procedures.
EH&S
  • Understand emergency procedures and follow safe systems of work, including maintaining good housekeeping.
  • Ensure compliance with environment, health and safety rules, signage and instructions at all times.
  • Ensure timely reporting and investigation of all accidents, near misses and breaches of rules.
Requirements/Qualifications:
  • Science or Engineering based degree (desirable).
  • Knowledge of the principles and guidelines for GMP.
  • Proven experience working in pharmaceutical manufacturing, it is desirable to have 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 target, demonstrating a 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).
Our globally distributed team of more than 100,000 colleagues delivers an unrivalled 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, Patheon and PPD. For more information, please visit www.thermofisher.com.Thermo Fisher Scientific is an EEO/Affirmative Action Employer, and we do 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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Deadline: 14-06-2024

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