1. Drive and coordinate activities of media fill and smoke study in XDP facilities.
2. Discuss media fill and smoke study as required with regulatory agencies, quality assurance, or clients, as required.
3. Lead and complete the routine and specific media fills of XDP facilities, including authoring media fill protocols/reports, prepare materials for media fill, execute the batch records, collect the documents etc.
4. Responding to client’s requirements on media fill, such as strategy, risk evaluation, etc. And support the function leader to present the topics related to media fill and smoke study with clients.
5. Authoring protocol, prepare instruments, organize a group of operators to take videos, summarize the report etc.
6. Maintain the SOPs of media fill and smoke study at the latest industry standards.
7. Serve as an investigation driver for the XDP team to ensure timely and accurate completion of high-quality manufacturing investigations and implementation of subsequent corrective actions.
8. Drive investigations to timely closure through collaborative efforts with cross-functional teams, including Operations, Quality Assurance, Engineering, MSAT, and other functional areas, as needed.
9. Author the change controls, follow up the execution status and close the changes in time.
10. Lead routine client audit and regulatory audit.
Minimum Requirement
1. Must be resourceful, self-reliant, self-motivated, and confident.
2. Good communication, organization and coordination skills.
3. Proficient English skills in listening, speaking, reading and writing.
4. Advanced computational capabilities (e.g. Data Analysis, Trending and computing with multiple variables) .
5. Demonstrate a sound understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing/packaging processes.
6. Experiences with GMP quality systems, including change control, deviations, and CAPA. Experience with cGMP software such as Trackwise/Master Control preferred.
7. Bachelor or above degree in Pharmaceutical Science, Pharmacy, Bioengineering/Chemical Engineering or relevant majors, as appropriate
8. Minimum 5+ years’ experience in similar position for bachelor degree and 2+ years experiences in similar position for master degree.