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Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change

Quality Manager APIs & Strategic Raw Materials

Job Tasks & Responsibilities:

• Establishes and maintains QA agreements between BCC, API & Raw Material suppliers or between BCC and BCC customers

• Manages quality related topics for example but not limited to risk assessments, deviation investigation and others for the suppliers which he/she is assigned to

• Change management: QA representative of the BCC API& raw material evaluation team: reviews, evaluates changes received from suppliers, performs QA approval within the Change Management System Synaps, supports and controls change implementation

• 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

• Responsible to follow up with the suppliers assigned on the CAPA audits outcome

• Ensures that all processes in BCC AG are established, maintained and implemented for all triangulated materials through Basel

• Contributes to the deployment/implementation of the API & SRM team strategy as well as contributes to the overall Quality and Product Supply Strategies

• Accountable and responsible for analyzing/ reporting KPIs regarding API & SRM to the Quality Management BCC AG

• Contributes to the implementation/deployment of PSS in the API & SRM team

• Divisional support:

  • Assures coordination with suppliers and CH sites and provides expert feedback for Issue management on API/ Excipients/ Herbals/Packaging materials

  • Supports CH sites with regards to any Quality topics related to supplier qualification and evaluation, Risk assessments, among others

  • Participates in audits/GMP assessments whenever requested to support the QA&I organization

  • Supports the CH site network by establis
    hing Divisional Quality Agreements whenever the sites are unable to negotiate them

  • Participates in project teams for identified issues with QA and regulatory impact (e.g. SWATs)

  • Drafts/Reviews Global Regulations whenever requested, but at least for topics such as supplier qualification for all types of materials

  • Deputy of the Quality BP APIs and Strategic Raw materials and Q/PM API & SRM

Job Requirements:

• Education in Life Sciences (Chemist or Chemical Engineering)

• At least 5 years of experience in the areas of Quality Control, Quality Assurance and / or Manufacturing of APIs in the Pharmaceutical/Food industries

• Experience in international quality management is essential for this function

• Knowledge of international and cGMP-, ICH- requirements and other quality assurance guidelines

• Knowledge of supply chain processes

• Excellent communicative skills are mandatory for international interaction

• Excellent teamwork, process/result oriented, change management skills

• Fluent in English is a must, any other languages is a plus

Location:

Division:

Consumer Health

Reference Code:

340229