Hands-on experience and understanding of automated systems supporting manufacturing, IT infrastructure, Engineering and operations.
Strong understanding and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
Assist in review and preparation of process/production equipment validation and computer systems validation
Review and approval of all Data Integrity - related activities and training including periodic reviews and status report to management
Improve and add to existic Data Integrity knowledge base, identify training requirements and serve as SME for the same
Serve as Validation Point of Contact and thus review all validation/qualification documents related to facilities, utilities and equipment.
Train all site personnel in validation area, provide training and prepare for both internal and external audit and investigations that follow
Hands on Computerized Systems Validation GAMP5/21CFR
Requirements:
Minimum 5 years in Quality Management Systems and Proficient in leading Validation, Computerized Systems/SDLC, Change Management, Manufacturing Quality, Deviation Investigation, Data integrity, Audits and Compliance, Documentation Control, Training Management and CAPA management
Minimum bachelor's or master's degree
GMP & GDP Certificate is plus
Well versed with Regulatory Guidelines - USFDA, EU GMP, PDA, PICS, 21CFR, BPE, ISPE, USP 1050 , GAMP5, ISO, WHO etc
