Senior Quality Engineer in Solothurn

veröffentlicht
Kontakt
Benoit Rochat, Genf Professionals Health Care & Life Sciences
Jobtyp
Festanstellung
jetzt bewerben

job details

veröffentlicht
Ort
Solothurn
Sektor
Life Sciences
Jobtyp
Festanstellung
Referenznummer
16390
Kontakt
Benoit Rochat, Genf Professionals Health Care & Life Sciences
Telefon
058 201 54 40

Stellenbeschreibung

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!