Validation and Compliance Specialist

Responsibilities: 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 f...