Qualification & Validation (CSV) Specialist
Posted on Dec 3, 2019 by Michael Bailey Associates - UK Contracts
Join the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, that has proven expertise in providing development, production and packaging services for pharmaceutical and biotech companies.
For our growing production site l specializing in sterile technologies, we are currently looking for a Qualification & Validation Computerized System Validation (CSV) Specialist
The Qualification & Validation Specialist reports to the Qualification & Validation Manager and will be responsible for Computerized System Validation activities (including production and QC lab) and is involved in routine Qualification & Calibration activities. The ideal candidate is a driven professional who has expertise in the field of Computer System Validation. What we offer is an exciting role in a dynamic team, as well as a chance to further develop your skill set and grow within an international company.
- 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
- Master 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 persistence
- Stress resistant
- Risk analysis thinking
- What we offer is an exciting role, a chance to grow and learn new skills in a global company, and in the most challenging quality environment within the pharma industry - a sterile business
- Potential for personal development within an international company
- Defined career path and annual performance review and feedback process
- Contributory pension and benefits package all offered from day one of employment
- 36 days' holiday + bank holidays
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.
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€400 - €450 Daily