& Job Description
Ensure that all operation systems design, implementation and execution are compliant with applicable validation, cGMP, and regulations and requirements across Kujira campus. Areas of responsibility cover facilities and utilities, DQ, IQ, OQ, PQ, PPQ, cleaning, calibration, computerized systems, Lab and test method validation and qualification “on-site”
Maintenance of team (10%): For execution of validation on-site, must establish team cross-functionally with internal resources and vendors
Execution of validation on-site (60%): Focus on IQ, OQ, PQ and Cleaning validation for the time of being with full responsibility on Cleaning validation, preparation of SOPs and validation protocols are required.
Act as DI manager (30%): On-site Computerized System Validation with full responsibility on CSV, preparation of SOPs and validation protocols as required.
Provide advice in the introduction, coordination, monitoring and analysis of validation - and compliance processes
Support colleagues and managers during visits, audits or contacts with Regulatory Agencies
Training, specific theoretical knowledge and functional experience
Randstad Enterprise is the leading global talent solutions provider, enabling companies to create sustainable business value and agility by keeping people at the heart of their organizations. As part of Randstad N.V. — a global talent leader with revenue of € 25.4 billion — we combine unmatched talent data and market insights with smart technologies and deep people expertise. Our integrated talent solutions – talent acquisition (RPO, MSP, services procurement/SOW and talent BPO) delivered through Randstad Sourceright, and talent development and transition (talent mobility, career coaching and outplacement) delivered through Randstad RiseSmart – help companies build a skilled and agile workforce that moves their business forward.
