Kırklareli, Türkiye
Data Integrity CSV-experienced Good Team Leader Self motivated Result and time oriented Share-based Dedicated to learn and implement Open minded Good coordination skills GLP/GMP leadership Specialties: computerised system Validation, data integry, GAMP5, EU Annex-11, FDA 21 cfr part 11, MHRA DI Guide, change management, computer skills, gmp, software Validation, hplc, management, process engineering, project management, quality, quality control, risk management, sop, validation
Data Integity Implementation Activities for Computerised Systems Data Integrity Gap Analysis Data Integrity Awareness Trainings Data Integrity SOPs Managing and execution of Computerized Systems Validation activities. Weighing Systems : MES : Werum Software&Systems Chromatographic Data System: CDS : Empower Area Monitoring Systems Optical Control of Vials System Performing trainings in validation and qualification subjects Generation and Training of SOPs for Computerized Systems such as; Computerized Systems Validation Guide, Change Management, Test and Deviation Management, Electronic Records and Electronic Signature, Risk Management, Periodic Review, Decommissioning, IT Application and GXP Compliance. Assessment of 21 CFR Part 11 Compliance. Project Management. Coordinating analytical laboratory equipment(computer based) qualifications Coordinating the production equipment qualifications Internal and external audits.
Preparation of Validation Policies and Procedures Preparation of Validation Master Plan Lead the computerized system validations Lead change management and deviation processes in CSV activities Establishment of CSV Strategy and rules. Implement all EU / FDA cGMP Regulations/Guidelines for computerized systems. Support new projects from GMP Compliance and Validation perspectives. Support GMP Compliance Department regarding Change Control, Deviations, Complaints, Internal and External Audits.
Execution of HPLC Analysis Lead Quality Control Lab. Instrumental Analysis
Lead and manage ISO 9001 Quality System Certificate Activities Manage Quality Assurance and Control Activities Products Release