Corporate Training and Document Management Officer M/W


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Stellen-ID: 46302
Standort: Wien, AT
Karrierestufe: Professionals
Fachbereich: Quality
Beschäftigungstyp: Permanent position


Headquartered in Lachen near Zurich, Switzerland, the Octapharma Group is a leading company in the worldwide market for therapeutic human proteins. Working at Octapharma means to have an opportunity to contribute to our common goal - developing lifesaving therapies to improve patients’ lives.Headquartered in Lachen near Zurich, Switzerland, the Octapharma Group is a leading company in the worldwide market for therapeutic human proteins. Working at Octapharma means to have an opportunity to contribute to our common goal - developing lifesaving therapies to improve patients’ lives.

 

We are seeking:

A motivated professional to join the corporate Quality organization as the Corporate Training and Documentation Management Officer. The position reports to the Head of Corporate Quality Assurance. The role will be based in either Vienna, Austria or Stockholm, Sweden or Lingolsheim, France.

 

Main responsibilities:

Responsible for the GxP Training Process managed by our Learning Management System. Responsible for defining GxP requirements for the LMS and for ensuring that the system is compliant with relevant SOPs and regulations.

Responsible for the Documentation management Process managed by our Electronical Documentation Management System, and responsible for the data produced by the system.

Responsible for defining GxP requirements for EDMS, and for ensuring that the system is compliant with relevant SOPs and regulations.

Trainer of LMS and EDMS users

Backup support for the EDMS system administrator managing User Access, IT-ticket system and User support.        

Support qualification/validation activities of updates/upgrades of IT application systems      

Participate in the development and harmonization work of the Pharmaceutical Quality System at Octapharma Corporation                    

                           

Your Profile:

You have a university or college graduation in M.sc. in engineering within bioscience or similar.

You have previous 5 years of working experience in pharmaceutical industry and experience to work with various IT system applications in Pharmaceutical Industry.

You have excellent English language skills in oral and written form.

You have profound knowledge of current GMP (Eudralex Volume 4 and US Code of Federal Regulations), including Part 11 and Annex 11 for computerised systems and Annex 15 for qualification/validation.


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