6 of 6 21 CFR Part 11 Jobs

translated, and delivered effectively. Leads requirement gathering & documentation across CDM, Biostatistics, and vendor partners. Translates business and regulatory needs into functional specifications aligned with 21 CFR Part 11, GxP, and HIPAA. Supports validation frameworks, audit-ready documentation, and reporting requirements such as Power BI dashboards … Pharma, Healthcare, Clinical Data Management, Biostatistics). Proven ability to gather, document, and validate requirements; conduct workshops; create functional specifications; ensure compliance with FDA 21 CFR Part 11, GxP, HIPAA Knowledge of regulatory frameworks including 21 CFR Part 11, GxP, HIPAA, GDPR ...

data integrity. Responsibilities Provide overall compliance oversight for all GxP computerised systems across Pharmanovia Ensure systems comply with regulatory expectations, including EU Annex 11, 21 CFR Part 11, GAMP and MHRA data integrity guidance Develop, implement and maintain computerised systems validation and lifecycle management processes … management of (CAPA, Deviation, Change Controls, Complaints, PQRs, Management Reviews, recalls, Strong knowledge of: Good Manufacturing Practice (GMP) and GxP EU Annex 11 21 CFR Part 11 GAMP 5 Data integrity principles and MHRA expectations Experience supporting or leading regulatory inspections and audits Required Skills ...

GAMP 5 related computerized system validations, including designing, authoring, executing, and coordinating. Direct experience operating in a medical device QMS environment, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, General Principals of Software Validation, Electronic Records/Signatures. Additional Experience applying knowledge of standard concepts … Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.). Experience with the following: - QMS - ISO13485:2016 - 21 CFR 820 QSR, 21 CFR Part 11 Electronic Signature, 21 CFR 801 Labeling - GAMP Good Practice Guide ...

environment, with exposure to: PLC/SCADA/DCS systems (Rockwell/DeltaV environments) Batch control systems and automation strategies GMP/GAMP/21 CFR Part 11 compliance Process equipment such as: filtration systems fluid handling systems bioprocess-style equipment Clean utilities and building systems … process control systems Desirable Experience Exposure to platforms such as DeltaV, FactoryTalk or ControlLogix Experience with batch processing and process automation Knowledge of GAMP, 21 CFR Part 11, S88/S95 Experience with: bioprocessing systems CIP/COP/autoclaves cleanroom or controlled environments Why This ...

systems used globally. Keywords: Radiopharmacy, Nuclear medicine, PET/SPECT, LIMS, Project delivery, System implementation, Validation (IQ/OQ/PQ), GMP, GAMP 5, 21 CFR Part 11, Annex 11, Compliance, SME, Customer-facing, Stakeholder management, Training, UAT, Software validation, IT systems, Deployment, Upgrades, Support ...

diagnose and resolve system issues; Effective communication and coordination skills to work across multidisciplinary teams; Basic knowledge of regulated environments and industry standards, including: 21 CFR Part 11 EU Annex 11 The preceding job description had been designed to indicate the general nature and level … Holiday Travel; Extra vacation days; Opportunities to learn and develop: training programs; Personalized career path within the organization; Exposure to an international environment as part of a multicultural team spread across Europe. Diversity & Inclusion Here at the Stefanini Group, we value plurality and equity, regardless of race, sexual orientation ...