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QC Manager

Isle of Man   •  £55000 - £65000 per annum + + Bonus   •  Permanent, Full time

A growing biopharmaceutical company requires an experienced QC Manager to lead its manufacturing team. You will be responsible for managing raw material, in-process and final product testing. The role is focused on the chemistry QC but will also involve oversight of microbiology testing. You must be an experienced team leader/manager with significant chemistry experience, particularly in GC, HPLC and/or AKTA.

Principle Responsibilities:

  • Responsible for the management of the Quality Control laboratory (QC) including Micro lab within the IOM facility reporting to the Director of Quality and Regulatory Affairs.
  • Responsible for the development of QC personnel using appraisals, training and mentoring.
  • Responsible for maintenance of the test schedule in support of production and batch release and ensuring capacity is appropriate.
  • To ensure all equipment is budgeted, sourced, qualified, maintained and calibrated as required.
  • To ensure that both the QC lab and Microbiology lab are safe and suitable.
  • To support troubleshooting of equipment, analytical and production processes.
  • Responsible for maintenance of the laboratory key performance indicators.
  • To ensure Lab Investigation reports, Out of Specification (OOS) processes are followed including Root Cause Analysis.
  • To ensure all QC CAPAs, deviations and change controls are completed in a timely manner.
  • To work with Tech Transfer in introduction of new or modified test methods to ensure smooth handover.
  • Be an active participant of the management team by following-up agreed measures and activities.
  • To provide support to senior management including line manager on specific projects.
  • To ensure there is a culture of continuous improvement.
  • Other related duties/responsibilities as required.
  • To drive the removal of extraneous testing within the site in preparation for new products.

Qualifications & Experience

  • At least five years' experience from within the pharmaceutical, biotech or fine chemical industries on chemical and pharmaceutical testing.
  • Expertise in technical problem solving and troubleshooting processes over a wide range of instrumentation including GCs and AKTAs.
  • To have the expertise to look at new equipment such as NMR etc to enable a lean approach to QC testing.
  • Experience in microbiology and/or chromatography is an advantage.
  • Experience in successfully leading and managing a highly technical team.
  • Excellent communication, presentation and mentoring skills.
  • High levels of computer literacy, numeric and analytical skills.
  • Excellent attention to detail with an energetic and proactive outlook.
  • Excellent knowledge on Quality Management system
  • Experience in building out QC and Microbiology labs would be an advantage.
  • A strong background in Quality control processes within a Manufacturing environment.
  • You will have a natural ability to communicate at a technical level to difference audiences within your in house and external customer base.
  • To have experience in report writing and KPI management of QC.
  • Exhibits energy, drive, determination and continually 'raises the bar'.
  • Proven track record in working collaboratively with team members, peers and Senior Management.
  • Commercial and industry awareness.

You must have the right to work in the UK. Learn more

  • Agency: Cranleigh Scientific
  • Reference: 7362
  • Posted: 6th May 2022
  • Expires: 3rd June 2022

Cranleigh Scientific

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