Jobdetails

2018-09-18 Assure GMP compliant and timely execution of QC method validations/qualifications for QC analysis method (release, IPC, stability, process qualification
Titel

QC Scientist (f/m) - HPLC knowledge

Dienstort Orth an der Donau Niederösterreich Unternehmen Shire
Arbeitgeber entdecken
Beschäftigungsart Vollzeit Position ohne Personalverantwortung Gehaltsangabe 3.163,33 € /brutto Jetzt online bewerben

QC Scientist (f/m) - HPLC knowledge

Shire am 17.10.2018 in Orth an der Donau




QC Scientist (f/m) - HPLC knowledge

Job-ID: R0028093
Location: Austria - Orth an der Donau (Baxalta)
Category: Quality Documentation

The QC Scientist is responsible for GMP compliant implementation and maintenance of validated status of assays in QC laboratories by planning and documenting analysis method validations / qualifications in collaboration with the respective laboratory. The position leads and drives analytical assay investigations (OOS, CAPA, etc) and is involved in change control and preparation of submission documents for the respective analysis methods.
This position will be involved in assay transfer / qualification / validation activities of various analysis methods.

Job Details:

  • Assure GMP compliant and timely execution of QC method validations/qualifications for QC analysis method (release, IPC, stability, process qualification / process monitoring) implementation and maintenance
  • Manage activities to support key projects (e.g. assay transfers)
  • Plan ICH conform method verification/validations
  • Write protocols and reports for method verification/validations, method transfer and comparability studies as well as qualification documents for standards and reagents, and implementation of assay controls
  • Work closely with QC testing labs during execution of the validation / qualification work by the QC laboratory
  • Lead and drive analytical assay investigations (OOS, CAPA, etc)
  • Knowledge sharing of problems that were found and share solutions to drive continuous improvement
  • Review of compendial requirements on a regular basis
  • Create and review submission documents
  • Plan and document change requests related to analysis methods

Qualifications:

  • Technical or natural sciences background (chemistry, biotechnology, biochemistry, or similar)
  • Expertise with analytical methods (PCR, HPLC, ELISA)
  • Knowledge of analytical method verification/validation and critical reagent qualification and Statistical knowledge and experience with data analysis would be a plus
  • Experience in problem solving (facilitation and application of tools)
  • Knowledge of regulatory requirements concerning analytical test methods (EP/USP/JP)
  • Experience in the biotechnology and/or pharmaceutical industry
  • Six Sigma Greenbelt training would be beneficial but is not required
  • Fluency in German and English
  • Target-oriented teamplayer, problem solving skills
  • Analytical thinking

As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees – our biggest asset – who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.

We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!

The minimum salary for this position is € 3.163,33 gross per month (full-time); increased payment is possible. We are looking forward to your application!

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