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 d evelops and maintains constructive relationships internally and externally .
- Mindset for continuous improvement . Our Company Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com. Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths
- and break new ground in the drive to make millions of lives better. Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after
- as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations. Want to learn more? Visit https://www.boehringer-ingelheim.com