Senior Engineer
vor 3 Wochen
SENIOR ENGINEER (MANUFACTURING COMPLIANCE)
Permanent Position
Your mission:
The Senior Engineer (Manufacturing Compliance) authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations. He/she initiates and owns deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required. He/she supports the Head of Bulk and/ or Packaging Operations in monitoring quality and performance metrics and acts as a referee for the operational team for GMP systems, documentation and training. He/she acts as deputy to the Head of Bulk and/or Packaging.
Your profile:
- BS/MS in Engineering/Technical discipline or equivalent experience.
- 8 years' experience in pharmaceutical validation, packaging or related field.
- Knowledge of current international regulatory regulations (cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP).
- Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc).
- Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes.
- Well-developed ability to constructively work across functional areas and levels to achieve results.
- Strong verbal and written communication skills.
- Strong analytical, problem solving, influential and deductive skills.
- Capability to work with short deadlines and simultaneous activities.
- Excellent organizational and project management skills.
- Successful experience in direct people management.
- Fluent in English and in French.
Gi Life Science is part of Gi Group Holding, a global ecosystem of HR services and consulting that supports the development of the labour market and helps to change people's lives in 37 countries around the world.
In Switzerland we operate with the brands Gi Life Sciences, Gi Group, Grafton, BauTech and former Kelly Services. We are active in temporary, permanent and professional staffing as well as in a variety of complementary HR Services. With a direct presence in 35 locations across Switzerland and over 250 employees, we are one of the leading staffing companies in the Swiss recruitment market.
Gi Life Sciences is specialist for Temporary and Permanent staffing in the Life Science sector, as well as a valuable partner for many other HR Solutions. We believe in experts talking to experts: all our professionals are certified in scientific sector, meaning that they are able to understand your needs and support you at 360°.
Your contact at Gi Group:
Marko Durakovic & Manon Tenaud
Gi Life Sciences Geneva
(marko.durakovic@gigroup.com & manon.tenaud@gigroup.com)
+41 22 737 12 07 & +41 22 737 12 09
Branche: Pharma-Industrie
Funktion: Ingenieurwesen/Planung
Anstellungsart: Festanstellung
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