|職種名||アニマルヘルス部門 COQA Asia Manager|
|仕事内容||1.Quality interface on business teams managing contractors
2.Development and negotiation of quality agreements
3.Support the establishment and implementation of necessary QA/QC systems with contract manufacturers
4.Support new product launches and technology transfer projects
5.Support development and maintenance of quality systems
6.Support product release and troubleshooting quality problems
7.Support continuous improvement programs at contract manufacturers
8.Apply technical expertise in cGMPs during Quality audits of contractors independently develop action plans and lead negotiations with contractors to provide resolution of issues identified
9.Actively participate in and lead industry/regulatory forums on contract manufacturing oversight and networking both inside and outside
|応募資格||1.A minimum of 10-12 years experience in the pharmaceutical industry with relevant QA/QC/Mfg experience is required, preferably with prescription products and a minimum of 10 years applicable product quality assurance experience.
2.A minimum of 5 -7 years of experience in API/DP along with some exposure to product quality assurance is required.
3.An exposure to contract manufacturing QA is highly desirable.
4.Supervisory experience is desirable
5.Demonstrated ability to apply global cGMPs and QA/QC system requirements, practices, and theory, preferably associated with manufacture of Human and Animal products
6.Demonstrated experience in managing quality and compliance activities in a manufacturing plant or with a contractor