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 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 15 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
- Preferred Six Sigma black and green belt certified as it is mandatory for the project prerequisite.
- GMP & GDP Certificate is mandatory
- Well versed with Regulatory Guidelines – USFDA, EU GMP, PDA, PICS, 21CFR, BPE, ISPE, USP <1050>, GAMP5, ISO, WHO etc.
