(Contract) CQV Engineer
to author and execute qualification protocols independently Strong working knowledge of cGMP (21 CFR 210/211, Part 11, EU Annex...
to author and execute qualification protocols independently Strong working knowledge of cGMP (21 CFR 210/211, Part 11, EU Annex...
by PPL EU management. Proactively identify risk and mitigation plans, monitor project status, recognize negative trends...
/211, 820, Part 4 (combination products), EU Annex 11, and data integrity requirements Manage document review/approval...
210/211, Part 11, EU Annex 11), ASTM E2500, GAMP 5, and ISPE guidelinesExperience with electronic documentation...
with 21 CFR 210/211, 820, Part 4 (combination products), EU Annex 11, and data integrity requirements Manage document review...
and drive high-quality CT submission deliverables across the US, EU, and China. Key Responsibilities Execute regional CT... submission strategies aligned to the global plan for US, EU, and China. Prepare, review, and coordinate regulatory documents...
with cross-functional teams. Preferred Qualifications: Experience with multi-country tax setups (US, Canada, EU, LATAM...
, and suppliers. Familiarity with FDA Quality System Regulations and Pharmaceutical guidelines, 21 CFR Part 210 & 211, US and EU...
CFR Part 210 & 211, US and EU regulations, ICH guidelines and other industry standards. ISO understanding is a bonus...
The ONLY requirement is: -To have an EU citizenship or passport. Anyway, TOEFL or other certification for teaching...