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Sr. QA Coordinator Technology Operations

Bayer Consumer Care AG

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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.

Sr. QA Coordinator Technology Operations

Executes oversight of strategic projects and device related
activities including quality and regulatory requirements,
prioritization, problem solving, and escalation to management.
Provides highly scientific evaluations of issues intended to mitigate
business and compliance risk and supports management. Uses
resources across sites, departments to achieve strategic objectives.
Supports and serve as QA subject matter expert for technology
transfers, process validation, cleaning validation, analytical
methods validation, other CMC studies, and new products launch
activities.
Provides input into the technology transfer, process, cleaning and
methods validation documents and of the Quality Management
Systems supporting operational and release functions.
Writes and reviews SOPs for validation and other projects.
Reviews and approves documentation of CMOs and relevant
sections of CTDs.
Coordinates necessary change management activities,
documentation, and proposes requirements for technology
transfers, process validation, cleaning validation, analytical
methods validation, other CMC studies, and new products launch
activities.
Maintains a contemporary understanding of cGMP regulations and
guidance in relation to all aspects of validation, technology transfer
and provides input to local, global procedures and directives.
Provides support for regulatory agency inspections and requests
Assures regulatory and cGMP compliance in line with approved
dossiers and with all relevant quality guidelines at all times and in
all markets
Interacts directly with suppliers and CMOs