Quality Assurance Specialist H/F

Essential tasks and responsibilities :

• Editing and issuance of qualification documents as well as final reports and GMP related
  documents (risk analysis, technical reports, etc.)
• Execution of qualification of equipment, utilities and machines, process validation and
  cleaning validation processes
  
• Analysis and evaluation of KPI and data monitoring to ensure a continuous improvement of the quality system
• Deviation and Change Control management
  
• Quality investigations and definition of corrective and preventive actions
  
• Definition of Standard Operating Procedures (SOP) and GMP-related documentation along with other relevant units/ department Managers
• Contribution to the implementation of innovative industrial Projects.
  
• Involvement in self-inspections and in third parties inspections
  
• Drawing of validation protocols, and final validation and qualification reports
  
• Definition of staff training plans and coordination of training and education activities.
  
• Cooperation with production and maintenance to define Gantt of shutdown activities and in
  general Gantt for qualification activities in order to have close alignment.
  

More specifically, the position includes the following tasks:

• Plan and coordinate validation activities in collaboration with the concerned department
  manager.
  
• Develop and maintain relationships with external validation service suppliers and planning
  their interventions.
  
• Based on the documentation, deliver Training to employees who are involved in validation
  activities.
  
• Participate to issue the Validation Master Plan and the Validation Project Plans related tothe industrial projects.
• Accomplish planned validation tasks, with the support of external or internal staff.
  
• Assure that the installation of new machines and utilities is performed according to relevant
  documentation (QD, IQ, QO, etc.).
  

Required skills and core competences

• Bachelor/Master degree in technical scientific subjects (Chemistry, Pharmacy, Engineering
  or equivalent)
  
• 5 years' experience in the pharmaceutical field, production, or quality assurance
  
• Expertise in injectables anesthetics (Production) and terminally sterilized products will be
  
• considered an asset.
• Good knowledge of the pharmaceutical industry and expertise in pharmaceutical
  manufacturing and GMP procedures will be considered an asset
  
• Fluent in spoken and written Italian and English, knowledge of French will be considered
  an asset.
  
• Excellent communication skills, proactivity, autonomy, precision, teamwork aptitude.
  
• Management and organizational skills, flexibility, learning agility and strategic thinking.
  
• Commitment to continuous improvement.
  
• Preference will be given to candidates of Swiss nationality and residents (Permit B -C)

 

Louise Terzo

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