IT Systems Validation Consultant

One of our clients, a multinational company in the pharmaceutical industry currently requires an IT Systems Validation Consultant with knowledge of the pharmaceutical industry

Start: January 2014
Length: min 6 months
Location: South of Brussels

FUNCTION DESCRIPTION:

Responsible for the validation of QC analytical systems and data reduction softwares.

KEY RESPONSIBILITIES:

* Computerized analytical systems validation:
- writing of IQ/PQprotocols, specific ones or particularized from generic templates and all others documents needed for validation
- execution of IQOQ 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 andfirst 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 environmentand a matricial organization

Experience

* Minimum 2 years experience in validation
* Obligatory 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 analyse the working of complex spreadsheets (multiple formulas and logical tests)

TRAINING PERIOD

Training period: 2 months

Tags: analytical systems, 21 CFR 11, Engineering, Validation, Datareduction, HPLC, pharmaceutical, pharmaceutique