Head of Quality (Director)
- Company
- 외국계 제약회사
- Position
- Head of Quality (Director)
- Status
- CLOSE
외국계 제약회사에서 다음과 같이 "Head of Quality (Director)”를 찾습니다.
* Job Title: Head of Quality (Director)
* Gender: Male or Female
* Location: 경기도
* Report line: APAC Quality Head
[RESPONSIBILITIES]
- Promote a positive approach on quality throughout the organization
- Provide quality support to manufacturing
- Work closely with the Global Corporate Quality and Operations and Compliance Team as required
- Report the effectiveness of the Quality Management System. File the agreed Key Performance Metrics monthly as required by the Corporate Quality management, monitor the performance and help in identifying areas that requires improvement
- Respond to corporate queries about the state of quality in company, and contracted organizations, and suppliers
- Keep abreast with the requirements including latest trends in GMP and attend suitable training to meet those needs
- Review Technical Agreements with 3rd Parties as required, and work with Corporate Quality as needed
- Provide wide-ranging support to the Group Quality Team and other personnel in Quality and Operations
- Lead the organization on any regulatory, customer, and external audits
- Preparation of programs for corrective and preventative actions (CAPA) after inspections conducted by regulatory bodies, customers, and other external organizations
- Approval and monitoring of the manufacturing and control, both on-site and from 3rd party providers (CMO’s and Testing Lab), suppliers of API, Packaging and other materials
- Follow-up Auditee’s CAPA on observation found after Audits and ensure close out
- Lead and oversee the investigation of complaints and recalls related to non-compliance with Quality on products manufactured at site and 3rd party Toll Manufacturer
- Manage QC and QA staff, which includes objective setting of individuals and conduct regular review of personnel performance in line with Local and Global Corporate standards
- Manage and establish budget of the Quality organization and input on the overall annual Budget Management Process. Monitor costs and take appropriate actions, where necessary
- Any other Quality Management Task as required
[QUALIFICATIONS]
- Pharmacist (Korea) preferred
- University degree in pharmacy (preferably a Master's degree) so that the person can be registered with MFDS. The person must not have been deprived of legal capacity to hold a position in the pharmaceutical industry
- Professional experience – preferably 10 years, but not less than 5 years, of uninterrupted work experience in the production and/or control of pharmaceuticals
- To be well acquainted with the MFDS standards, and preferably also European standards on Good Manufacturing Practice (EU-GMP) and Good Laboratory Practice (GLP), as well as other international GMP standards
- Good computer skills
- Good command of Korean and English
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
Email: ceo@exdigm.com
