QC Instrumentation Qualification Expert
Thermo Fisher Scientific, Inc.
Swindon, United Kingdom
2d ago

Job Description

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 more than $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.

At our site in Swindon, ThermoFisher are forging partnerships that are transforming the industry, creating new business models between pharma companies and their pharma service providers.

We are pioneering solutions that are driven by client needs, with successful recent partnerships including Flexion and Pacira.

We currently offer solutions spanning the entire pharmaceutical life cycle to help pharma and biotech companies of all sizes meet their complex development and manufacturing needs at any stage or scale enabling us to deliver a combination of unrivaled quality, reliability and compliance, backed by a reputation for scientific and technical excellence.

The range of services at ThermoFisher for drug substances and drug products is wider than that of any other CDMO and we offer end-

to-end capabilities and expertise to take your discovery from pre-clinical and clinical development, through scale-up, all the way to commercial supply across more than 40 oral solid, sterile and softgel dosage forms.

Key Accountabilities

  • To lead, plan, coordinate and execute timely calibration and qualification of all QC laboratory equipment across the QC labs ensuring equipment is kept in a state of control and compliance
  • Ensure QC equipment calibration and qualification activities are planned, effectively tracked, monitored and achieved in accordance with agreed timelines
  • Writing & execution of protocols and reports (URS / DQ / IQ / OQ / PQ), organisation of qualification work into packages suitable for audit presentation
  • Completing routine performance checks and calibration duties on analytical laboratory equipment as specified in the calibration schedule
  • Maintain and control a visual management system of qualification, validation and calibration activities
  • Assisting in maintaining a clean working environment within the QC Laboratory
  • Collaborate and coordinate initiatives with other QC Supervisors and Mangers
  • Regularly generate and provide detailed update reports for Quality and Site management
  • Generate and prepare quality documents e.g. SOP’s and controlled documents
  • Lead and / or support investigations into issue impacting analytical equipment
  • Review & approve deviation and any change proposals related to analytical equipment issues
  • Act as SME for the above with regulators / clients (i.e. key part of audits and inspections)
  • Ensure own KPI actions, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines
  • Ensure standard lead-times are adhered to and support Business Unit and Corporate goals (e.g. RFT and OTD, OTIF)
  • Ensure own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.
  • g. SOP’s, analytical methods, Protocols, Guidance’s, etc.

  • Ensure own training is undertaken in a timely and GMP compliant manner before the task is undertaken
  • Identify and drive Practical Process Improvement initiatives (PPI)
  • Undertake / support Self-inspections, GEMBA walks and Huddle meetings as relevant
  • Undertake ad-hoc activities that may be required by the business
  • Support and encourage a Quality Culture and company 4i values throughout QC
  • Experience

  • Relevant science-based degree; e.g. Chemistry, Biology, Pharmacy
  • Experience working in a pharmaceutical QC function, preferably within a sterile site
  • Substantial Technical experience, must have minimum 5 years’ and hands-on’ knowledge working with calibration and qualification of analytical systems such as balances, HPLC, GC, Chromatography Data System (CDS) such as Waters Empower software, UV, IR with the ability to maintain & troubleshoot these systems
  • Extensive experience of instrumental and traditional analytical techniques
  • Communication skills must be able to speak, listen, and write. Hold presentations, facilitate meetings and trainings, and create reports
  • Good Collaboration and Conflict resolution skills
  • Good technical writing skills
  • Wants to learn and have a natural curiosity to understand systems and processes
  • Ability to work in a fast paced environment essential
  • When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

    The information that you have provided in your cover letter and CV will be used to assess your application.

    Thank you for your interest in this opportunity.

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