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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.
QA Manager Steriles
Main contact of external partners and internal partners for all QA
related topics with regards to the radiopharmaceutical injectable
Prioritize and manage CMO related topics and action items and
uses resources across sites and across departments to achieve
Lead teams to provide highly scientific evaluation of issues
intended to mitigate business and compliance risk while
maintaining product supply of radiopharmaceutical injectable
product with regard to strength, purity, and potency.
Manage QAAs with CMOs and participate in contract
negotiations and supply agreements.
Support Product launches of the product with regards to QA,
radioprotection and radiosafety requirements and their
Support complaints, projects, change control, deviations, and
provide training to staff members, and ensures that CMOs are
adhering to Bayer standards and expectations. Responsible for
resolving production discrepancies as related to product release,
which must take into account all manufacturing processes, quality
testing and customer requirements.
Provide complex tracking and trending analysis relevant to
Maintain awareness of current GMP trends and manufacturing
processes and radiopharmaceutical requirements and ensures
appropriate implementation in Bayer systems
Support continuous improvement within the Quality Unit
Provide support for audits, regulatory agency inspections and