Technical MS&T Support

· Responsible in conducting the gap analysis of sending unit versus receiving unit and risk assessment includes but not limited to material, process, equipment, utilities, contamination strategy and etc for GMP readiness, successful water run and engineering run

· Support on the preparation (author or reviewer) of MS&T documentation such as validation plan, master batch record, protocol, and protocol report for technical transfer on the timely manner and accurate.

· Support on the change control execution activities and follow up on the closure.

· Responsible in setting up, and drafting documentation from scratch, and ensuring MS&T documentation/procedures are in line with the latest guideline with health authority and industry standards. Conducting gap analysis as needed.

· Collaborate with cross functional teams, locally and globally on technical transfer related activities.

Professional experience, skills and competencies

· Experience in the (aseptic) production of vaccines under GMP conditions. Have experience in process development/MS&T department/ tech transfer activities.

· Organized and structured way of working, understanding of quality.

· Agile and solution oriented. Willingness to go into detailed, responsibility for one’s own and self-driven.