QA Validation Specialist

QA Validation Specialist

Join Nalys!

At Nalys, we’re passionate about innovation, quality, and people. As a fast-growing consultancy company specialized in high-tech engineering and life sciences, we partner with industry leaders to deliver impactful solutions. We’re currently looking for a QA Validation Specialist to join one of our key pharmaceutical clients in Belgium. If you thrive in a dynamic environment and want to contribute to the highest standards of quality and compliance, this opportunity is for you.

Your Responsibilities

As a QA Validation Specialist, you will play a critical role in ensuring the compliance and robustness of validation activities across various departments. Your main responsibilities will include:

• QA validation for equipment and system qualification (DQ, FAT/SAT, IQ, OQ, PQ, requalification, periodic assessments)
• Cleaning validation protocols and reports
• New product introduction (batch records, engineering studies, PPQ protocols/reports, method validations)
• Media fill validation and operator qualification
• Routine calibration records
• Facility qualification and classification post-maintenance
• Deviations, QCA, and OOS related to validation activities
• Enforcing Computerized System Validation (CSV) policies and procedures
• Reviewing and approving validation and qualification documentation (URS, DQ, FAT, SAT, IQ, OQ, PQ, SOPs)
• Participating in deviation investigations and root cause analysis.

Your Profile

• You own a scientific university degree (Pharmacist, Engineer, or equivalent) with a minimum of 3 years of experience in validation and/or QA within the pharmaceutical, biotech, or medical device industry
• You act as an expert in GMP regulations and in validation and qualification of equipment, systems, and processes
• You are able to perform assessments and interpret data effectively
• You have an analytical and detail-oriented mindset
• You are able to work under pressure and meet tight deadlines
• You are fluent in French and English.

Recruitment Process

By applying for the QA Validation Specialist position, you will go through the following steps:

1. Olivia Braszko, TA Specialist at Nalys, will review your application and schedule a first screening
2. You will meet with our Technical Director, Alexandre Ivankovich, and the TA Specialist for a deeper discussion
3. Final interview with our Business Unit Director, Jimmy Rousseaux.