Sr Quality Engineer - Cleaning Validation

Panda International; Geel; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Innovative Medicine Geel seeks a Sr Quality Engineer (QA) specialized in cleaning validation to oversee the site's validation program and ensure cGMP compliance. You will provide QA oversight on cleaning validation actions and review protocols, reports, and deviations to maintain regulatory compliance.

In this role you will collaborate with MSAT and Operations, drive risk-based decisions, and contribute to cross-functional teams, applying strong ownership, timely delivery, and fluency in English

Qualifications

• Master's degree in a scientific discipline and 10 years of pharma/chemical experience.
• Strong knowledge of cGMP/cleaning validation compliance (EU cGMP, ICH Q7, 21 CFR Part 211).
• Hands-on cleaning validation experience with QA oversight responsibilities.
• Ownership mentality, timely delivery and strong risk-based decision making.
• Fluent in English and Dutch, with cross-functional communication skills.
• Ability to operate across organizational boundaries as part of One Team.

Responsabilités

• Ensure all cleaning validation regulatory and procedural requirements are fulfilled.
• Provide strategic input to the compliance improvement plan for cleaning validation.
• Deliver QA oversight on cleaning validation actions within the System Based Compliance action plan.
• Review and approve cleaning validation documents - SOPs, risk analyses, validation protocols & reports, tests, trend reports, changes, and deviations.
• Collaborate with MSAT, Operations, and other teams to introduce new cleaning validation concepts and methodologies.
• Advise and support cleaning validation activities, safeguarding cGMP aspects in new projects, and contribute as a member of multi-functional teams on cross-departmental objectives.

Connaissances

Cleaning validation

cGMP knowledge

Quality assurance

Regulatory compliance

Risk management

Cross-functional collaboration

Analytical thinking

Time management

English language

Dutch language

Formation

Master's degree in a scientific discipline

Description du poste

Sr Engineer QA Cleaning Validation

Location: Geel, Belgium

Innovative Medicine Supply Chain Geel serves as the center of excellence for the development and manufacturing of SM-APIs and DP Intermediates used in treatments that improve the health and lifestyle of people worldwide. Innovative Medicine Synthetics Quality (IMSQ) supports the Geel site in its mission as a Launch & Grow site, ensuring quality oversight and final release of APIs and DP Intermediates to guarantee reliable, compliant supplies.

As Sr Quality Engineer, you will act as the Subject Matter Expert for cleaning validation, providing quality oversight across the site's cleaning validation program.

Your responsibilities:

• Ensure all cleaning validation related regulatory and procedural requirements are fulfilled
• Provide strategic input to the compliance improvement plan for cleaning validation
• Deliver QA oversight on cleaning validation actions within the System Based Compliance action plan
• Review and approve cleaning validation documents - SOPs, risk analyses, validation protocols & reports, tests, trend reports, changes, and deviations - to maintain compliance with regulations, guidelines, and company policies and standards
• Collaborate with MSAT, Operations, and other teams to introduce new cleaning validation concepts and methodologies
• Advise and support cleaning validation activities, safeguarding cGMP aspects in new projects, and contribute as a member of multi-functional teams on cross-departmental objectives

What you bring:

• Master's degree in a scientific discipline, or equivalent experience
• 10 years of experience in the pharmaceutical or chemical industry
• Strong knowledge of cGMP/cleaning validation compliance (EU cGMP, ICH Q7, 21 CFR Part 211) and quality risk management (ICH Q9)
• Hands-on experience with cleaning validation
• Strong sense of ownership and a quality-driven mindset, with a track record of delivering on committed timelines
• Sharp analytical thinking and the flexibility to work under time pressure
• Sound judgment for risk-based decision-making, with an understanding of the business implications of quality positions and decisions
• A proactive, accurate way of working across organizational boundaries, as part of One Team
• Fluency in English and Dutch, both written and verbal, with strong cross-functional communication skills