Senior Quality Engineer

☞ Randstad Switzerland

View: 159

Update day: 22-04-2024

Location: Solothurn Solothurn SO

Category: Quality Assurance / Quality Control

Industry: Staffing Recruiting Biotechnology Pharmaceuticals

Position: Associate

Job type: Full-time

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Job content

Do you have a strong quality background in a manufacturing environment ? Do you want to develop your career in a renowned life science company ? You should then read the following lines!

One of our clients, based in the Solothurn area, is looking for a Senior Quality Engineer for a permanent position.

Tasks
  • You provide support to manufacturing areas within the facility for upcoming deviations and CAPAs related to equipment and automation of the production process and applying regulatory and compliance knowledge from multiple markets/agencies.
  • You review and approve complex GMP documentation (Changes, plans, protocols, technical documentation, etc.) related to modifications of existing equipment and automation and may participate on projects requiring a high knowledge level of regulatory, Quality and Process systems.
  • In addition, you support ongoing production and maintenance processes reviewing and approving related work orders in the electronic maintenance management system (EMMS).
  • You work with the senior Quality Engineering Team to identify/revise/develop and implement complex Quality systems that can be global in scope
  • You ensure adherence to internal procedures for facility/equipment controls and release before, during and after production operations (i.e. routine operations, shutdowns, construction projects, product changeover, etc.)
  • You interact with regulatory agencies directly during audits as well as providing input into such documents as regulatory filings (may be expected to act as primary author for sections of filings)
Profile
  • You have a bachelor’s Degree in a relevant field such as Chemical Engineering, Mechanical Engineering, Bio-Engineering, Automation Systems, Computer Science
  • You bring a broad level of experience in a pharmaceutical or biotech manufacturing environment. With at least a solid previous experience within Quality Assurance, Validation or another related function. Automation/MES or related functions are preferred.
  • You have and maintain knowledge of relevant FDA/EMA regulations and compliance.
  • You have experience in validation of production equipment or cleaning utilities, automation systems and knowledge of production methodology involved in bio-pharmaceutical production.
  • You have the ability to work in cross-functional teams
Do those lines sound familiar to you ? Do not waste any second and apply now!
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Deadline: 06-06-2024

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