QA Validation Expert

Vor 4 Tagen


Neuchâtel, Schweiz Randstad Vollzeit
Jobdescription
For ourclient, an international company based in Neuchâtel, we are lookingfor a Quality Assurance Expert – Engineering /Validation.

Within this position, QA Expertis responsible for Quality Assurance in the frame of activities allalong the manufacturing and release process.

General Information:
 
  • Start date:ASAP
  • End date: 1 yearcontract
  • Extension: possible, to bediscussed
  • Workplace:Neuchâtel
  • Workload:100%


Tasksand responsibilities:
 
  • Acts asQA representative for both routine GMP activities and companyprojects.
  • Acts as the Quality partner withinProduction Unit Team, the Quality Control laboratories, Warehouseand Engineering/Maintenance/Validation departments asapplicable.
  • Ensures quality and integrity ofinformation within systems and documentation in respect to currentguidelines, compliance and regulatoryrequirements.
  • Supports and works in line withthe “QA on the shopfloor” requirements (for example through GMPaudits or events management).
  • Responsible forquality aspects during the Validation Activities (routine andprojects).
  • Shall promote and be involved inContinuous Improvement.
  • Understands and appliescompany EHS guidelines and commitment policies, takes care of itsown safety, reports risk situations and improvement opportunitiesto supervisory personnel


Your profile:
 
  • At least 2years of experience in a GMPenvironment
  • University degree in Engineering,Biotechnology, Pharmacy or Quality Management applied to industrialprocess or equivalent experience in pharmaceutical and /orbiotechnological companies
  • Fluent French and agood command of English
  • Demonstrate the companyValues of Integrity, Fairness, Honesty, Perseverance as a naturalway of working
  • Good knowledge of FDA, EMA, ICHregulations, Pharmacopeias and Quality systemstandards
  • Knowledgeable in auditing andinspection against regulatory / Qualitystandards
  • Knowledge/Experience with Qualitytools such as TrackWise
  • Good analytical skillsand ability to simplify the complex
  • Solutionoriented and team spirit
  • Good listener andcommunication skills
  • Good organizational skillsand continuous improvementmindset

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