Partner to implement and troubleshoot end-to-end solutions, supporting a robust and scalable environment. Compliance and Regulatory Adherence Ensure all processes adhere to industry standards, GxP regulations, FDA 21CFRPart11, and internal governance frameworks. Monitor system performance and integration functionalities to support audit readiness and risk mitigation. Qualifications & Experience Hands-on SAP functional More ❯
Partner to implement and troubleshoot end-to-end solutions, supporting a robust and scalable environment. Compliance and Regulatory Adherence Ensure all processes adhere to industry standards, GxP regulations, FDA 21CFRPart11, and internal governance frameworks. Monitor system performance and integration functionalities to support audit readiness and risk mitigation. Qualifications & Experience Hands-on SAP functional More ❯
correctly and align with the company EDMS whilst adhering to procedures for Document Control. Cross-check documents with pre-existing quality documents. Provide document drafting, review and approval as part of equipment and software purchase and implementation. With the help of management and quality teams link quality work instructions to pre-existing SOPs. Ensure smooth day-day administrative operations … in/with Regulatory and Validation teams and QA would be beneficial. Having drafted User Requirement Specification, Validation Plans and be aware of IQ/OQ/PQ and 21CFRPart11 would be advantageous. Strong IT skills and knowledge of Microsoft Office Suite, principally, Word. Excellent organisational and time-management skills. Excellent record keeping More ❯
