1 of 1 21 CFR Part 11 Jobs in Berkshire

documentation, plan, schedule, and execute validation activities of the QMS software utilizing a risk-based approach. Ensure compliance to medical device industry regulations, including 21 CFR Part 11, EU GMP Annex 11, and EU GDPR. Supply Chain Responsibilities: • Validate, implement, manage, and maintain … manufacturing processes and international logistics. • Knowledge and experience with processes and ERP systems with regards to supply chain activities. • Project management skills as part of cross-functional development teams, • Excellent working knowledge on FDA QSR requirements and ISO 13485. • Good working knowledge on MDSAP requirements. • Demonstrates strong attention ...