Head of External Clinical Supply Quality
, and quality systems. Areas of expertise should include compliance, quality assurance, quality control, validation, technical...
, and quality systems. Areas of expertise should include compliance, quality assurance, quality control, validation, technical...
, adding and suggest control or mitigations, identifying gaps). Possibly, support the Unit to edit remediation plans for gaps...
, Failure Investigations, Change Control, Qualification/Validation activities and associated documentation approval. Drive the...
across sites Ensure alignment with current regulatory expectations, including : EU GMP Annex 1 (2022), Contamination Control... Annex 1 (2022);USP - Microbiological Control and Monitoring of Aseptic Processing Environments;21 CFR Part 211 and FDA...
activities on quality systems (CAPA, Deviation, Change Control, …) related to automated and computerized systems. Support team...
. Ondersteunen van de implementatie van nieuwe testmethoden en analytische procedures binnen Quality Control Operations...
and “SOSD†(See it, Own it, Solve it, Do it) attitude within Patient Supply Quality Control. Deliver general cGMP training... levels. Support regulatory inspections/audits, providing dynamic assistance to SME's. PATIENT SUPPLY QUALITY CONTROL...
solutions that enhance efficiency, control, and insight within the tax function. This role provides a unique opportunity...
d'implémentation de ces stratégies (Change Control, autres) – Déterminer les impacts validation sur base des release notes.... o Identifier l'approche d'implémentation de ces stratégies (Change Control, autres). o Planifier, organiser et coordonner...
you the space to take control of your own development and growth. We believe in entrepreneurship and initiative and want...