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Analytical QC Professional
Eingestellt von Michael Bailey Associates - Munich
Gesuchte Skills: Support
Projektbeschreibung
We are recruiting for a Quality Control Expert within AS&T for solid oral drug forms such as tablets and capsules.
You will be involved in several projects as a subject matter expert for the validation of analytical test methods. This is a 1 year contract position and requires fluent German.
Responsibilities
* Project manager and subject matter expert for the development, improvement, validation of analytical test methods for the analysis of pharmaceutical products
* Create and validate method validation plans and reports
* Assessment of new analytical methods, specifications and method validation from development, compliance with regulatory requirements, GMP guidelines (eg ICH) and established standards.
* Assistance in the planning and implementation of method transfers
* Scientific and technical support and technical contact person of the laboratory group in the AS & T team for the project-specific concerns
* Support of the work team for process validation in technical questions and evaluation of analysis data in connection with process validation.
* Assessment and processing of OOS/OOE cases
* Compliance with applicable SOPs and cGMP guidelines
Education & Experience:
- MSc or PhD in Analytical Chemistry
- 5+ years experience in instrumental analytics (HPLC or GC, UV, etc) and broad knowledge/experience with various analytical technologies and validations.
Please call Luchele Mendes for further details or send CVs
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
You will be involved in several projects as a subject matter expert for the validation of analytical test methods. This is a 1 year contract position and requires fluent German.
Responsibilities
* Project manager and subject matter expert for the development, improvement, validation of analytical test methods for the analysis of pharmaceutical products
* Create and validate method validation plans and reports
* Assessment of new analytical methods, specifications and method validation from development, compliance with regulatory requirements, GMP guidelines (eg ICH) and established standards.
* Assistance in the planning and implementation of method transfers
* Scientific and technical support and technical contact person of the laboratory group in the AS & T team for the project-specific concerns
* Support of the work team for process validation in technical questions and evaluation of analysis data in connection with process validation.
* Assessment and processing of OOS/OOE cases
* Compliance with applicable SOPs and cGMP guidelines
Education & Experience:
- MSc or PhD in Analytical Chemistry
- 5+ years experience in instrumental analytics (HPLC or GC, UV, etc) and broad knowledge/experience with various analytical technologies and validations.
Please call Luchele Mendes for further details or send CVs
Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges