10 of 10 Remote 21 CFR Part 11 Jobs

connect process development to manufacturing, enabling faster, more reliable tech transfer and batch release. Ensure architecture patterns comply with Life Sciences regulatory frameworks: GxP, 21 CFR Part 11, EU Annex 11, GAMP 5and data integrity requirements. Collaborate with client quality and regulatory affairs teams ...

connect process development to manufacturing, enabling faster, more reliable tech transfer and batch release. Ensure architecture patterns comply with Life Sciences regulatory frameworks: GxP, 21 CFR Part 11, EU Annex 11, GAMP 5and data integrity requirements. Collaborate with client quality and regulatory affairs teams ...

technical stakeholders. A practical, commercially aware and solutions‐focused approach. Experience with LIMS, ELN platforms, laboratory systems, GxP, MHRA guidance or FDA 21 CFR Part 11 would be particularly valuable. What’s next? If you are an experienced IT leader who enjoys combining strategy with hands ...

authoring policies and procedures (SOPs). Experience conducting audits and gap assessments. Experience managing internal personnel, contract resources, and projects. Expert knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents. Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting documents ...

authoring policies and procedures (SOPs). Experience conducting audits and gap assessments. Experience managing internal personnel, contract resources, and projects. Expert knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents. Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting documents ...

authoring policies and procedures (SOPs). Experience conducting audits and gap assessments. Experience managing internal personnel, contract resources, and projects. Expert knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents. Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting documents ...

authoring policies and procedures (SOPs). Experience conducting audits and gap assessments. Experience managing internal personnel, contract resources, and projects. Expert knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents. Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting documents ...

authoring policies and procedures (SOPs). Experience conducting audits and gap assessments. Experience managing internal personnel, contract resources, and projects. Expert knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents. Expert knowledge of FDA, EU, and MHRA GxP regulations and supporting documents ...

cross-functional teams across Engineering, Data Science, Product, and Quality. Strong knowledge of QMS, Computer System Validation (CSV), GxP, GAMP 5, ICH-GCP, and 21 CFR Part 11. Familiarity with evolving AI regulations, including the EU AI Act and FDA/EMA guidance on AI. Responsibilities: Lead ...

mapping and gap assessments , and supporting the rollout of new or enhanced systems aligned to global regulatory standards (including GMP, GDP, GCP, GLP, FDA 21 CFR 210/211, EU GMP/EudraLex, ICH Q7/Q10). Authoring, reviewing and maintaining quality policies, standards, SOPs, forms ...