CMC Quality Solutions Specialist H/F/X

Beschrijving van de functie

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.

Jouw profiel

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.

Taalvaardigheden

• Frans (troef)

  • Begrijpen : Vaardig - (C1)
  • Schrijven : Vaardig - (C1)
  • Lezen : Vaardig - (C1)
  • Spreken : Vaardig - (C1)

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