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Quality Assurance Manager IMP QP

Eingestellt von Real Staffing Group aus Frankfurt am Main

Gesuchte Skills: Marketing


The role responsibilities include:

* Ensure the requirements of the Clinical Trial Authorisation/Marketing Authorisation and Manufacturing Licence are met for every batch released.
* Enforce principles and guidelines of Good Manufacturing Practice in Directive 2003/94/EC (human)
* All necessary checks are performed and an account taken of production conditions and manufacturing records.
* Planned changes or deviations in manufacturing and quality control are recorded in a well-defined reporting system before any product is released.
* Any additional sampling, inspection, tests and checks are carried out, as appropriate to cover planned changes and deviations.
* All necessary Production and Quality Control documentation are completed and endorsed by supervisors trained in appropriate disciplines.
* Ensure all requirements for imported products are met.

The successful candidate will have the following attributes:
* Proven management experience in an MHRA/FDA regulated environment, with an excellent working knowledge of current ICH, EU andUSregulatory requirements and their implementation.
* Extensive relevant experience in Pharmaceutical Clinical Trial Quality Assurance.
* Previous man management experience

If you wish to apply for the position, please send an updated CV to John Morkus or call 0207 758 7311 for further information.

To find out more about Real Staffing please visit www.realstaffing.com


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  • Berufserfahrung:

    Keine Angabe

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Real Staffing Group

  • Straße:

    Grosse Bockenheimer Strasse 50

  • Ort:

    60313 Frankfurt am Main, Deutschland

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