For our customer located in Neuchatel/Switzerland we are currently looking for a: Quality Assurance Specialist (m/f/d)

• Home office is not applicable for this position

Tasks & Responsibilities

This individual will perform Quality Assurance activities associated with commercial cGMP biologics drug substance and drug product manufacture at Neuchatel site.

As Team player, this person is mainly responsible for review of batch records and associated documentation in the controlled atmosphere production area as well as the approval of documentary change requests. This person provides assistance to site personnel performing deviation investigations, CAPAs and change controls.

• Performs documentation review thoroughly, with a high attention to detail, using working knowledge of quality concepts and internal procedures and controls.
• Supports GMP compliance with time spent in the Manufacturing environment on a regular basis.
• Report any potential issue detected on the floor and propose adequate guidance for documentation and correction.
• Identifies and resolves basic technical issues using problem
• Provide quality oversight, i.e.support and guidance to production team units in their routine activities directly on the floor, fostering strict application of cGMP concepts and quality systems.
• Participates in required training and keeps training files current.
• Identifies and proposes Quality Process and system improvements.
• Performs additional duties, as assigned.
• Perform various administrative tasks and any other relevant task per request.
• Be flexible to support the activities of the operational QA team according to business needs.

Must Haves

• CFC, BAC+2 or equivalent degree or equivalent in Engineering, Biotechnology, Pharmacy, or Quality Management applied to industrial process or equivalent industrial experience preferred, and/or 3-5 years experience in Regulated (food, medical device, or pharma/biotech) industry.
• Understands and applies good working knowledge of quality and GMP principles.
• Ability to handle multiple tasks concurrently and in a timely fashion.
• Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
• Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers and management.
• Must be able to read, write and converse in French.
• Must display eagerness to learn and continuously improve.
• Positive work attitude that supports teamwork and continuous improvement.
• Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
• Must be experienced in Microsoft Office applications, especially Word, Excel and PowerPoint.
• Wrist and hand motion (e.g. typing, writing)
• Must be able to work in controlled or clean room environments requiring special gowning

Did we catch your interest? 

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.