Internal Operations Quality Partner H/F/X

Beschrijving van de functie

Contracting - Brabant Wallon

The role is within the Clinical Supply Quality team, focusing on packaging and labeling for clinical studies. The position is critical for ensuring quality systems and compliance in the production, release, and distribution of Investigational Medicinal Products (IMPs) for clinical trials. - Review of batch records (both electronic and paper). - Review and release of labels. - Release of warehouses and production consumables specification. - Update of CEC (Controlled Environment Conditions). - System-related activities: deviation review, CAPA (Corrective and Preventive Actions), change control. - Temperature excursion management. - Validation activities related to computer design systems. - Documentation review for operational production activities. - KPI realization based on specific requests. - Participation in audits, regulatory inspections, and vendor management. - Support for qualification, validation, and maintenance of equipment and facilities.

Jouw profiel

- 3 to 5 years of relevant experience required. - Pharmaceutical experience is essential; QA/compliance experience in a pharmaceutical regulated environment. - Proficiency in Excel (KPI creation, pivot tables). - Hands-on operational QA experience is important and will make a difference. - Good knowledge of cGMP and relevant regulatory requirements (e.g., US, European, Japanese). - Technical affinity (e.g., point of contact for equipment validation). - Dynamic, energetic, and communicative personality, able to challenge and express opinions. - Fluency in English and French. - Preferably a Master's degree in engineering or similar for the right mindset. - Ability to function with minimal supervision, strong organizational and analytical skills. - Fact-based decision-making and problem-solving skills (failure investigations, risk analysis). ---- No QP (Qualified Person) number required, but QP training is a plus. Nice to Have: - Certified auditor by official authorities. - Eligibility to act as a QP in the EU. - Experience in leading internal audits/self-inspections. - Familiarity with regulatory submissions and CMC (Chemistry, Manufacturing, and Controls) documentation.

Taalvaardigheden

• Frans (troef)

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

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