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Quality Manager API & Strategic Raw Materials
This position holder, through his / her activities, is a critical part of assuring that the Active Pharmaceutical Ingredients and Strategic Raw Materials used in production facilities are safe for customer and patients producing for Bayer Consumer Care, are in compliance with the legal requirements (e.
g. ICHQ7, EU GMP guide part I and II, IPEC and ISO), and are in compliance with the submitted regulatory files. This is achieved e.
g. through managing manufacturers and suppliers, evaluating and qualifying them, evaluating impact of changes and
deviations reported by these suppliers as well as managing the GMP documentation system for supplier qualification (DaQS database).
Act as Quality representative in front of main stakeholders (Procurement, Technical, Supply) within the Leadership Teams.
This position holder directly reports to the Quality BP APIs & Strategic Raw Materials with main focus on GMP compliance of internal and external API production.
Scope (global, regional or local) :
Key Tasks :
2) Manages quality related topics for example but not limited to risk assessments, deviation investigation and others for the suppliers which
3) Change management : QA representative of the BCC API& raw material evaluation team : reviews, evaluates changes received from suppliers,
4) Responsible for keeping header data assigned to him / her maintained and ensuring that supplier qualification documentation is up to date, complete and state of the art for these suppliers.
5) Responsible to follow up with the suppliers assigned on the CAPA audits outcome.
6) Ensures that all processes in BCC AG are established, maintained and implemented for all triangulated materials through Basel.
7) Contributes to the deployment / implementation of the API & SRM team strategy as well as contributes to the overall Q and PS Strategies.
8) Accountable and responsible for analyzing / reporting KPIs regarding API & SRM to the Quality Management BCC AG.
9) Contributes to the implementation / deployment of PSS in the API & SRM team.
Key Tasks : Divisional support :
Divisional support :
10) Assures coordination with suppliers and CH sites and provides expert feedback for Issue management on API / Excipients / Herbals / Packaging materials.
11) Supports CH sites with regards to any Quality topics related to supplier qualification and evaluation, Risk assessments, among others.
12) Participates in audits / GMP assessments whenever requested to support the QA&I organization.
13) Supports the CH site network by establishing Divisional Quality Agreements whenever the sites are unable to negotiate them.
14) Participates in project teams for identified issues with QA and regulatory impact (e.g. SWATs).
15) Drafts / Reviews Global Regulations whenever requested, but at least for topics such as supplier qualification for all types of materials.
16) Deputy of the Quality BP APIs and Strategic Raw materials and Q / PM API & SRM.
Qualification & Competencies :
Any other languages are an advantage.