A global leader in Bio-Similar pharmaceutical company is seeking a 'CMO Controller' as follow;

[RESPONSIBILITIES]
1. Schedule manufacturing slot and necessary activities (i.e., procurement) at Contract Manufacturing Organizations (below; CMO) and other external service provider (below; supplier)
2. Identify and monitor key operational performance indicator for CMO (incl. other supplier)
3. Work as primary contact for innovation, investigation, and CAPA activities associated with CMO (incl. other supplier)
4. Support change management in packaging specification or label information among Regulatory Affair, Development division, Supply Chain Dept, and supplier
5. Closely communicate site quality issue (i.e., nonconformance, deviation, OOS, change control, compliant, and recall etc.) between QA and CMO (incl. other supplier) based on corporate quality management system
6. Verify suitability, qualification and validation of processes at CMO (incl. other supplier) to meet required time line with supply chain dept.
7. Drive process innovation for manufacturing process with process analytical tool
8. Develop innovative solutions with CMO (incl. other supplier) to reduce cost/delivery time and improve efficiency
9. Write technical reports on a variety of manufacturing-related subjects
10. Maintain up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical product.
11. Occasional travel (i.e., supplier visits) may be required.

[QUALIFICATIONS]
- Bachelors in Biology, Chemistry, Engineering, or relevant science
- 4~8 years of work experience in commercial manufacturing for pen-injector combination product under EU and US cGMP/Quality System Regulation
- Expert knowledge in pen-injector assembly operation
- Expert knowledge in medical device regulation for combination product (i.e., 21 CFR part 4, ISO 13485)
- Expert knowledge in process validation and technology transfer
- Experience in Design History File (i.e., DHF) writing is a plus
- French or Italian speaking is a plus
- Excellent verbal and written communication skills in English
- Familiar with Microsoft Office application (MS word, MS excel, MS project, and MS sharepoint)

Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently  Only qualified candidates will be contacted for interview  All resumes not contacted will be kept in DB confidentially for future positions

Kyung Jin KIM
CEO & Executive Search Consultant
Exdigm Inc
Phone: 02-557-8272
Mobile: 010-8722-1272
Email: ceo@exdigm.com