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QA Compliance Expert, Neuchatel

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Location:

Neuchatel, Switzerland 

Job Category:

Healthcare

Salary:

CHF€0.00 - CHF €1.00
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Job Reference:

PR/105855_1623313993

Job Views:

39

Posted:

10.06.2021

Expiry Date:

25.07.2021
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Job Description:

QA Compliance Expert – Permanent French part of Switzerland
We have an interesting opportunity for a QA expert who is interested in further development in biotechnology therapies in particular in biologics . This role will support QA and compliance operation for manufacturing of biologics for clinical trials
Your daily tasks:

• Responsible for the review of facility validation studies, facility SOP and environmental monitoring
• Responsible for the monitoring of facility relates audit findings, deviations change control and CAPA
• Execute activities such as equipment /system validation to meet defined agreements
• Review and update Validation Master Plan, system/equipment qualification
• Optimise facility quality processes based on EU/FDA GMP requirements and guidelines.
• Draft facility quality assurance policies and procedures and update quality manual
• Perform trainings for other team members in the Quality field
• Provide support to preparation for audits and inspection
• Support KPI preparation and reporting

EDUCATION AND DESIRED EXPERIENCE:

• Bachelor’s degree or equivalent in life sciences, engineering, biochemistry, biology pharmacy
• 5 Years of experience in GMP environment and hands ‘on experience in quality
• Experience in cleanroom engineering, Manufacturing, Computer validation system and system Qualification.
• Experience in deviation and change control management including CAPA system.
• Excellent Interpersonal and communication skills
• Highly organized and ability to work both independently as well as part of a team
• Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the issues/discrepancies in a flexible and constructive manner
• Demonstrated skill in planning and organization, customer service, problem solving and proactivity

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.
Company Info
Michael Bailey Associates
12 Brook House, Chapel Place
London, United Kingdom
Phone: 00442077392022
Web Site: http://www.michaelbaileyassociates.com
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