CMC Quality Solutions Specialist
Contracting – Brabant Wallon
Your responsibilities:
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.
Your profile:
- 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.