• Bioanalytical Project Coordinator


• Research Technician/Assistant


• Research Technician/Assistant in Molecular Biology


• Clinical Operations Manager (based in Basel)


• QA Validation Specialist


• Clinical Document Specialist (based in Basel)


• Purification Development Technician/Assistant


• Clinical Database Developer


• Head of Purification & Drug Product Development

QA Validation Specialist

CAREER OPPORTUNITY

QA Validation Specialist

Novimmune SA is a drug discovery and development company located in Plan-les-Ouates and Basel, Switzerland, that focuses on developing therapeutic monoclonal antibodies for inflammatory diseases and immune-related disorders.

The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets. Each of these portfolio products has the potential of becoming a medicine for multiple medical conditions due to the intrinsic mechanism of action.

Novimmune is seeking a QA Validation Specialist (100%), based in Plan-les-Ouates, who will report to the QA Manager.

This person will provide technical expertise and QA support for validation activities associated with equipment, processes, facilities, and computer software/systems to ensure compliance with applicable current GxP regulations, applicable guidelines and site Standard Operating Procedures (SOPs).

Key responsibilities and accountabilities:

• Actively contribute to the definition, implementation and improvement of validation processes and practices. This includes the management of SOPs, working instructions and associated records.


• Work closely with the Novimmune departments and provide QA support in the design, development and execution of validation planning and related activities, through :


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  • Writing, review and/or approval of the validation documentation (e.g. URS, FS, IQ/OQ/PQ protocols and reports, validation plans, risk assessments…)
  
  
  • Execution and/or review of validation tests
  
  
  • Support the handling of anomalies and the definition of actions
  
  


• Support the Novimmune departments in the management and investigation of quality-related events (e.g. change controls, deviations) and in the implementation of CAPAs related to validation activities.


• Perform QA oversight of outsourced activities linked to validation: selection, qualification and monitoring of Vendors, review of documentation, audits and CAPAs follow-up.


• Provide support and contribute to specific projects (e.g. data integrity, implementation of electronic quality systems, LIMS), in regard to validation.


• Contribute to the staff training on validation topics.

Skills and competencies:

• Bachelor degree in engineering or scientific discipline


• At least 3 years of validation related experience in pharmaceutical or biotechnology industry


• Working knowledge of equipment, systems, method, process and facility validation in a pharmaceutical or biotechnology environment


• Good understanding of GxP guidelines (cGMP) and EU/US validation standards


• Ability to read, interpret and analyse technical documentation and guidelines


• Excellent technical writing skills and verbal communication skills (in both English and French languages)


• Strong organizational skills, ability to handle multiple priorities and to meet deadlines


• Ability to learn and to adapt to a changing environment


• Ability to work independently or within a team structure, and to develop collaboration with other departments


• Ability to take initiatives, strong analytical and problem-solving skills


• Computerized skills (MS Office)

If your profile matches the above description, please send us your CV, copies of your diplomas and motivation letter in English under the reference QA/VALID to the following email address: hr-recruitment@novimmune.com