Quality Assurance Architect 20624-1

vor 1 Woche

Bern, Bern, Schweiz We make it Vollzeit

Beschreibung:


We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience.

Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We at it GmbH set the highest standards for quality, ethics and discretion.

For our client, a renowned pharmaceutical company based in Bern, we are looking for an
Quality Assurance Architect (M/F/d)

Quality Assurance Architect M/F/d):

Background
CSL Behring is a global biotherapeutics leader driven by its promise to save lives.

In Bern more than 1800 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.


Task and Responsibilites

  • Supports creation and implementation of the aseptic operator training concept and program for an Isolator Filling Line at CSL Behring site Bern
  • Creation and update of procedures, risk assessments, concepts
  • Ensureses adherence to global CSL procedures and standards
  • Supports creation of the aseptic process validation concept for a new Isolator Filling Line and Lyophilisation process
  • Supports creation of aseptic process validation reports, protocols and procedures

You must have these qualifications

  • Language: German and English Business Level
  • Education: Degree in Life Sciences
  • Experience:


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 aseptic process validation (Media Fill validation), aseptic cleanrooms, process, equipment, consumables, aseptic behaviors and gowning
  • Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.
  • Looking for background in Sterility Assurance, sterile manufacturing, quality on the floor, aseptich operator training, aseptic process validation (Media Fill)
  • Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines.

Work hours

  • 41 h / Standard
**Are you interested?

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