JOBS

Back

QA Validation Manager (M/F)

March 24th 2020

MaSTherCell is a dynamic and global Contract Development and Manufacturing Organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies to the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, MaSTherCell’s teams are fully committed to helping their clients fulfil their objective of providing sustainable and affordable therapies to their patients. To lead its increasing number of development and manufacturing projects, MaSTherCell is looking for a highly motivated QA Validation Manager.

Mission Description

The QA Engineering Expert is responsible to implement and maintain the following quality systems:

Production, Area, Premise and Equipment

  • Subject Matter expert covering QA questions, related to qualification and validation processes.
  • Ensure the facility Validation Master Plan is in place and in use.
  • Ensure required Standard Operating Procedures and systems are implemented to support qualification and validation programs.
  • Provide quality oversight and support for cleaning, equipment, facility and instrument qualification and validation activities.
  • Provide expertise in the assessment of Change Control requests and provide support in the review of the associated risk assessment related to validation activities.
  • Provide QA support, including review and approval, for deviations, and investigations related to facilities, equipment, equipment failures ensuring events are contained, risks mitigated, impacts to equipment, product and processes adequately evaluated, root cause(s) identified and appropriate Corrective and Preventive Actions (CAPAs) implemented.

Computerized system

  • Subject Matter expert covering QA questions, related to validation of computerized systems.
  • Ensure that CSV program is in place and in use.
  • Ensures the review and approval of documentation related to computerized system, including user specifications, impact assesments, commissioning and validation protocols.
  • Maintain organized, updated and validated the document management system.
  • Provide expertise in the assessment of Change Control requests and provide support in the review of the associated risk assessment related to validation activities.
  • Provide QA support, including review and approval, for deviations and investigations related to Computerized systems and ensure events are contained, risks mitigated, impacts adequately evaluated, root cause(s) identified and appropriate Corrective and Preventive Actions (CAPAs) implemented.

Environmental monitoring

  • Subject Matter expert covering QA questions, related to Environmental Monitoring program.
  • Ensures the review and approval of documentation related to Environmental Monitoring, including procedures, qualification protocols & reports, forms and trends.
  • Provide quality oversight of the Environmental monitoring program.
  • Provide expertise in the assessment of Change Control requests and provide support in the review of the associated risk assessment related to EM.
  • Provide QA support, including review and approval, for deviations and investigations related to EM excursions and ensure events are contained, risks mitigated, impacts on GMP facilities, products are adequately evaluated, root cause(s) identified and appropriate Corrective and Preventive Actions (CAPAs) implemented.

Candidate profile

Obligatory Requirements :

  • Good knowledge of quality tools : cGMP, Validations and Qualifications, Regulatory guidelines, Handling or regulatory inspections, well acquainted with Change control / deviation and market compliance management system.
  • Expérience of minimum 3 years in Quality Assurance, Environmental Monitoring or Validation fonction with a strong familiarity of general GMP documentation and Equipment/Instrumentation (preferably in a biopharmaceutical company).
  • Experience with aseptic processing.
  • Knowledge of medical devices is a plus.
  • Team management.
  • Experience in cell therapy or quality control of human cells is a real plus.

Relevant requirements :

  • Critical mind.
  • Ownership.
  • Autonomous and organized.
  • Open mind.
  • Quality mind.
  • Fluency in French and English is a must.
  • Rigorous, conscientious, flexible and honest.

Offer

  • Full-time position (40h/week)
  • An Indeterminate contract
  • The opportunity to take part in a growing dynamic biotech company
  • A human-sized working environment with a convivial atmosphere
  • A company car with fuel card.

Contact Details

Please, apply on the following link MaSTherCell