Contractor Quality Assurance Architect (m/f/d)

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Bern, Schweiz |

Temporary Employment

Job title: Contractor Quality Assurance Architect (m/f/d)

Industry: Biotech
Skills: Quality Assurance, Aseptic, Training

Start of project: 07.06.2023

Duration of the project : 12 Months

Project volume: 2006 hours

Location: Bern, Switzerland

Tasks:

Supports creation and implementation of the aseptic operator training program
Creation and update of procedures, risk assessments, concepts
Creation of training content in the area of aseptic processing (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)
Training of operators for the aseptic processes and manufacturing in the area (Microbiology, Hygiene, Aseptic Behavior, Transitional spaces, gowning procedures)
Implementation of state of the art VR technology for aseptic operator training
Language: German and English Business Level
Education: Degree in Life Sciences Experience

Qualifications:

Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and cGMP compliance.
+5 years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing
Extensive professional experience in leading teams with respect to aseptic cleanrooms, process, equipment, consumables, aseptic behaviors and gowning and utilities
Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.

Referenznummer:

Branche:

Beginn des Projekts:

Dauer:

Anstellungsart:

Kontakt

Lars Uhl

13165

Biotech

07.06.2023

12 Monate

Temporary Employment