Responsible of the Validation of Analytical Systems and Data Reduction

For our partner in the Pharmaceutical Industry in Walloon Brabant we are looking for a RESPONSIBLE OF THE VALIDATION OF ANALYTICAL SYSTEMS AND DATA REDUCTION SOFTWARES

PLACE: Walloon Brabant

CONTRACT: contract/freelance

START: October 2013

DURATION: 6 months

Key Responsibilities

-Responsibility for the validation of QC analytical systems and data reduction softwares
-Computerized analytical systems validation:
- Writing of IQ/PQ protocols, specific ones or particularized from generic templates and all others documents needed for validation
- execution of IQ/OQ tests on computerized analytical equipments(with support of supplier if needed)
-Data reduction softwares validation:

Write and execution of:

- Tests to assess the 21 CFR 11 compliance
- Tests to validate calculations done mainly in Excel spreadsheet but also in Softmaxpro V5.3 GxP
- Support to QC Teams for the access management and first level of help on analytical softwares problems

Prerequisites

Education: Have an engineering degree (chemistry, pharma, biotechnology) or equivalent by experience

Knowledge

- Bilingual French/English
- Good communication skills
- Ability to work under pressure due to the requested flexibility and reactivity of the activities
- Autonomous
- Hands-on mentality
- Ability to work in project teams in a multidisciplinary environment and a matricial organization

Experience

- Minimum 2 years experience in validation
- Previous experience in one or more of the following validation areas: HPLC Waters, Elisa Readers Versamax, UV/IR/NIR spectrophotometers.
- Knowledge of Real Time PCR or Genetic sequencers would be a plus.
- Knowing of Excel 2007: be able to analyze the working of complex spreadsheets (multiple formulas and logical tests).

Training period: 2 months