Manager Qc Laboratory

vor 1 Woche

YverdonlesBains, Waadt, Schweiz Incyte Corporation Vollzeit

SUMMARY

The Manager QC Laboratory is responsible for the supervision of the QC Laboratory activities, to support analytical method validation, product testings (IPC, DS), raw materials testings, environmental and utilities monitoring.


DUTIES AND RESPONSABILITIES

  • Author, review or approve laboratory standard operating procedures and work instructions for the QC laboratory.
  • Ensure that all QC activities are compliant with with cGMPs and HSE guidelines.
  • Plan and be accountable for all activities required for the QC laboratory and Manufacturing operations (organization, raw material testing, physicochemistry and microbiology activities, environmental and utilities monitoring, laboratory work instructions,).
  • Responsible for the planning and the evaluation of workload of the laboratory and provide timelines to site departments.
  • Lead/support 5S organization of QC laboratory.
  • Ensure that all QC equipment are appropriately qualified and fit for purpose for cGMPs activities.
  • Lead the opening of deviations, CAPAs and investigations for the QC laboratory.
  • Provide inputs for establishing the QC laboratory budget and operating in the defined approved budget.
  • Act as a mentor to more junior team members and lead by example to ensure timely completion of laboratory objectives and proactively propose problem resolution.
  • Contribute to write protocols and reports
  • Lead review or approval of laboratory protocols and summary reports.
  • Support Analytical Tech Transfer of new processes to the Yverdon Manufacturing facility.
  • Maintain required consumable and raw material QC laboratory stocks.
  • Contribute positively to a strong culture of Lean Manufacturing, business integrity and ethics
  • Is the Quality champion for the QC department, responsible to drive a high level of quality in the department:
  • Monitor and report quality compliance indicators for the QC department
  • Chair Quality compliance reviews in the department
  • Implement quality compliance initiatives in the department in collaboration with QA and the Bioplant quality champion community
  • Coach and support other team members for quality compliance matters (such as deviation and changes management)
  • Coordinate the department inspection readiness
  • Act within compliance and legal requirements as well as within company guidelines
  • Delegate to: Diector Quality Control

REQUIREMENTS:

  • Biotechnology or pharmaceutical MSc degree preferred (e.g. Swiss HES, University, Engineering School) or relevant experience in the biotech industry.
  • A minimum of 5 years QC Laboratory supervision experience required with demonstrate ability to set vision and direction for a team including setting expectations and motivating results
  • Experience with Quality systems such as Deviation, CAPA, Change control systems required
  • Experience in troubleshooting, investigation, root cause analysis in a cGMP environment required
  • Leadership, ability to build trust and create collaborative environment and relationships
  • Ability to work in a fast paced highly regulated environment.
  • French and English (Fluent).
  • Team work oriented mindset.

Disclaimer:

The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.

They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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