QA Validation Expert
Vor 4 Tagen
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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