You have a relevant experience in Computer System Validation? You have good QA skills (CAPA, deviation, validation protocols, etc.)? You have project management skills and you are a good communicator? This job is for you!
For one of our clients located in Brussels areas, we are looking for Qualification & Validation Specialist Computerized System Validation. Our client is a pharmaceutical industry.
Qualification & Validation Specialist Computerized System Validation
The Qualification & Validation Specialist reports to the Qualification & Validation Manager. Will be responsible for Computerized System Validation activities (including production and QC lab) and is involved in routine Qualification & Calibration activities.
The tasks are as follows :
- Perform initial & periodical Computerized System validation for all GMP equipment at site (production & QC lab) 21 CFR Part 11
- Review and approve risk assessment link to CSV
- Performed routine Calibration & qualification activities
- Ensure that all activities are performed according to the schedule
- Ensure that all activities are properly documented
- Write qualification and validation protocols and reports and other documentation related to the activities
- Investigate deviations and execute CAPAs
- Define and execute improvement projects and initiatives
- Participate in customer and authority audits
- Can be involved in other process validation activities
- Degree in Biology/(Bio-)Engineering/Automation or equivalent
- Relevant qualification & validation experience in the pharmaceutical/agro-food industry
- Experience in Computer System Validation
- Fluent in French and English
- Integrity, positive energy and mind-set, team-player
- Excellent communication skills
- Accountability for results and persistency
- Stress resistant
- Risk analysis thinking
Our clients offer an exciting role in a dynamic team as well as a chance to further develop your skills. A permanent contract with an attractive salary package and extra-legal benefits (insurance, lunch vouchers, etc.).