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Validation Technician

Posted Date: 11-Jan-2022

Location: Eysins, VD, CH, 1262

Company: Quotient

Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial stage
diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced.  Quotient has two key product portfolios, Alba by Quotient and MosaiQTM by Quotient. The Alba by Quotient product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ™ is designed to be a game-changing solution, which we believe will increase efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins/Switzerland, Edinburgh/Scotland and Newtown/Pennsylvania.

 

VALIDATION TECHNICIAN

 

Quotient is recruiting for a Validation Technician to join the Operative Quality Department / Validation Team based in Eysins. The role is a full-time and permanent position.

 

The Validation Technician will ensure the task execution according to the validation plan, ensuring success at each of the identified phases in accordance with operational objectives, statutory and regulatory requirements and the principles of GMP.

 

JOB DESCRIPTION

The main responsibilities will include:

  • Preparation and execution of:
    • Qualification activities of new & existing equipment
    • Processes & cleaning validation;
  • Assist with development of validation protocols, risk assessments and reports;
  • Maintain inventory of validated equipment, processes and systems;
  • Interface between Validation and all areas to ensure validation issues communicated effectively and managed to ensure limited compliance risks & key relationships;
  • Development, preparation, collation and control of all validation documentation to deliver continued compliance with GMP, ISO9001 / ISO13485 standards, the IVD Directive, FDA Regulations and approved Health & Safety policies;
  • Report and participate to technical investigations into validation deviation, non-conformances and out of specification/ trend test results.

 

QUALIFICATIONS & EXPERIENCE REQUIRED

  • Bachelor degree in science or equivalent Engineering diploma;
  • Work experience in regulated environment (medical device or pharma industry);
  • Knowledge and expertise of core IT systems (Microsoft Office) and standard laboratory techniques and equipment;
  • Very good technical writing & reporting skills;
  • Ability to work in fast moving environment and respect timelines;
  • Must be able to communicate in a clear and concise manner;
  • Team player with ability to work under pressure;
  • Fluent in English (speaking & writing);
  • Infrequent travel to supplier or other Quotient site.