Computerized System Validation Project Manager

One of our clients, an international company in the pharmaceutical industry currently requires a Computerized System Validation Project Manager with knowledge of QC Analytical Methods

Start: ASAP
Length: min 6 months
Location: South of Brussels

FUNCTION DESCRIPTION

Responsibility for the validation of QC analytical systems

KEY RESPONSIBILITIES

- Computerized analytical systems validation
- Writing of IQ/OQ 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)
- Support to QC Teams for the access management and first level of helpon 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.

TRAINING PERIOD

Training period: 2 months

Tags: pharmaceutical, validation, analytical systems, QC, QualityControl, Computerized, system, validation, CSV