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Quality Control Analyst, Equipment Specialist

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Quality Control Analyst, Equipment Specialist

Modis is looking for one of it's clients a:

Responsibilities:

  • Performs master data management activities in computerized systems (e.g LIMS, Oracle, Empower, Dissolution Workstation, Tiamo, etc.)
  • Updates associated GMP documents and procedures.
  • Performs audit trail reviews, system periodic review, assures adherence to data integrity principles.
  • Provide first line contact with QC End Users and QA e-Systems in case of software issues.
  • Leads or supports investigations in case of system-related deviations.
  • Leads or supports corrective and preventive actions implementation related to Oracle or QC software.
  • Assists with errors and solve problems with minimum guidance; performs simple data fixes.
  • Owns or support change controls for QC software changes.
  • Provide end user training and on-the-job training for new employees where required.
  • Supports risk assessments
  • Participate in acquisition and qualification of new analytical equipment.
  • Works cross-functionally with the Analytical Development, QC, IT and Validation departments to select, purchase and qualify new analytical equipment for the QC
  • Owns or support change controls for QC equipment changes
  • Performs feasibility experimental work as needed
  • Configures user profiles and methods on the instrument.
  • Can be assigned special tasks and project work
  • Support laboratory investigations in case of equipment-related deviations. Defines corrective and preventive actions.
  • Support End-User with equipment troubleshooting
  • Supports risk assessments

Profile:

  • CFC as Laboratory Technician or BS degree in Science, Chemistry, or equivalent.
  • A minimum of 2 years of relevant work experience in a GMP regulated environment (or equivalent). Previous experience of laboratory equipment qualification is a plus.
  • Advanced knowledge and interpretation of cGMP, ISO, FDA, MHRA and Pharmacopeia requirements, and good documentation practices.
  • Good knowledge of Data Integrity principles, familiar with audit trail review requirements.
  • General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
  • Good knowledge of basic coding and code reviews.
  • Good knowledge of LIMS, Oracle and Empower applications.
  • Good scientific knowledge and hands-on experience of chromatography techniques (HPLC, UPLC, GC), dissolution, UV/VIS, potentiometry and IR techniques.
  • Effective verbal communication skills, ability to interact with different levels of the organization: supervisor, peers, lab analysts, and other departments
  • Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports) as well as deviations and investigations.
  • Professional command of French and English, verbal and written.
  • Proven time management skills and a strong attention to detail.
  • Proven analytical and problem-solving skills.
  • Ability to work independently and compliantly.
contact: geneva.lifesciences@modis.ch

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