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

[RESPONSIBILITIES]
- Scheduling product QC testing according to market demands
- Technical advising for handling lab exception or OOS related to product quality
- Monitoring GMP compliance related to contract QC labs
1. Work as primary contact for innovation, investigation, and CAPA activities associated with CMO or contract QC lab
2. Schedule analytical slot and necessary activities (i.e., procurement) at CMO or contract QC lab to meet required time line with supply chain Dept.
3. Closely communicate quality issue (i.e., nonconformance, deviation, OOS, change control, compliant and etc.) between internal QA and CMO or contract QC lab based on corporate quality management system
4. Verify suitability, qualification and validation of analytical method at CMO or contract QC lab
5. Identify and monitor key performance indicator for CMO or contract QC lab
6. Support analytical method transfer activities to prepare site addition or change
7. Write technical reports on a variety of analytical method-related subjects
8. Drive process innovation for supplier oversight and project management with process analytical tool
9. Develop innovative solutions with CMO or contract QC lab to reduce cost/delivery time and improve efficiency
10. Maintains up-to-date knowledge of US and EU GMPs and other regulatory guidance applicable to pharmaceutical production and QC testing

[QUALIFICATIONS]
- Bachelors in Biology, Chemistry, and/or relevant sciences.
- 7~10+ years of work experience in commercial biologics QC testing under EU and US cGMP
- Expert knowledge in analytical method validation and technology transfer
- Expert knowledge in impurities and stability study
- Site oversight/supervising experience in the pharmaceutical or biotech for analytical laboratory
- Full understanding of relevant GMP requirements, EP and USP requirements, ICH guidelines, and, EMEA and FDA guidance.
- Excellent verbal and written communication skills in English
- Knowledge and experience with a wide range of chromatography techniques, electrophoresis and bioassays including binding and cell based assay for antibody medicinal product
- Occasional travel (i.e., CMO and QC site visit) may be required.
- Familiar with Microsoft Office applications (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