Commercial Quality Specialist
THE POSITION
Support to the establishment, continuous improvement and maintenance of the Quality Management System at Boehringer Ingelheim Korea by ensuring that all external (e.g. Good Distribution Practice, Good Storage Practice, Korean regulation) and internal Boehringer Ingelheim requirements are implemented at Boehringer Ingelheim Korea.
Tasks & responsibilities
- Support Quality Management System of Boehringer Ingelheim Korea Human Pharma and Animal Health.
- Support the management of local quality operation/activities to ensure it is compliant to applicable regulatory
and Boehringer Ingelheim requirements.
- Ensuring the set up and maintenance of a document management system for local SOPs/ Working Instructions.
- Maintaining a library of all the relevant regulations and guidelines related to commercial product supply and
Distribution.
- Supporting Quality System, which includes Deviation, Complaint, Change Control, Risk, CAPA Management.
- Support Audit Management, which includes self-inspections, internal audits and authority inspections.
- Ensuring regular self- inspections at Korea to drive the continuous improvement program and to ensure
readiness for Corporate or Korean authority inspections.
- Managing audits by Corporate or inspections by local Authorities in respect to quality compliance.
- Ensuring adequate CAPA plans are established and tracked for audit/inspection completion.
- Support external 3rd party Management.
- Ensuring quality and regulatory compliance of products/ services which are out-sourced to external parties.
- Supporting quality audits at local suppliers and external parties (qualification and regular audit).
- Acting as first escalation to resolve quality issues from external parties.
- Release commercial batch as back up of authorized batch releasing person for Boehringer Ingelheim Korea Human Pharma.
- Supporting Batch disposition (release/ reject) for distribution of human pharma product in accordance with
Korean regulation as a back up of authorized batch releasing person.
- Supporting product launch which includes analytical method transfer and preparation of quality documents.
- Ensuring correct handling and storage of market returns, promotional and retention/reserve samples.
Requirements
- Korea Pharmacist License.
- Fluent Korean language and English communication skills are required.
- Minium 2 years of quality or regulatory function experience are preferred.
- Domestic business traveling.
- Attitude to develops and maintains constructive relationships internally and externally.
- Mindset for continuous improvement.