Jobbeschreibung

Positionsnummer / Reference Number

TA1205130032021

Position / Job Title

Quality System Specialist

Dauer / Project Length

12 months with an option to extend

Aufgaben / Tasks

- Assure precise and complete archiving of technical project documents in PUMA
- Manage GMP paper archive according to SOP
- Manage / file various quality relevant documents (QMS / GxP documents)
- Support QA by gathering and compilating of data for QA /QC and regulatory purposes
- Make sure QMS documents are up to date by contacting and reminding authors
- Provide assistance as part of health authority audits
- Responsible for training as well as support of PUMA and LIMS users
- Evaluate e systems for GxP compliance requirements
- Assist to system validations

Qualifikationen / Qualifications

- Master`s degree or higher in a scientific, medical or healthcare discipline
- At least 2-3 years of working experience in a professional related field in the pharmaceutical industry
- Experienced with PUMA or other QMS
- Communicative personality with an eye for details and excellent organizational skills
- Business fluent in English

Weitere Informationen / Further Information

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