CMC Quality Solutions Specialist

Contracting – Brabant Wallon

The role is transversal and supports CMC Quality Leads rather than being assigned permanently to a single product.Reviewing and assessing Material of Contact documentation, including extractables & leachables data and risk assessments.
Supporting complaint committee activities, including trend analysis, data challenge, deviation follow-up and preparation of solid QA positioning.
Contributing to process improvement strategies for complaint management, especially in preparation for FDA inspection.
Drafting or reviewing QA documents, deviations and risk-based justifications
Participating in meetings with internal stakeholders (mostly in English).
Challenging incoming documentation on a daily basis and providing QA decisions.
The role requires autonomy, strong critical thinking and the ability to operate in a non fully stabilized environment.

• Minimum 5–8 years of relevant experience, the role is not suitable for junior profiles.
• Solid experience in Material of Contact (including Extractables & Leachables).
• Strong background in Complaint Management within a GMP / Pharma environment.
• Proven ability in deviation management, root cause analysis and CAPA -definition.
• Strong QA mindset and risk-based decision-making skills.
• Fluency in English & French.
• Ability to work autonomously and be force of proposal in evolving processes.
• Nice to have :Experience in GMP audits and inspections (FDA exposure is a plus).
• Experience in CMC / regulatory submissions.
• Data integrity or project management experience.
• Ability to support additional QA activities on products if capacity allows.

Bedrijfswagen

Our offer ?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, Toon emailadreslena.palmeri@jeffersonwells.be