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.
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