Data Integrity Engineer - Quality Operations
Job Description
Overview
This position performs as QA partner with Business Technology and has the responsibility to drive compliance improvements identified in the Waco site’s Action Plan, relating to electronic systems compliance across the manufacturing network.
Responsibilities
Maintain a program to comply with the requirements of the FDA, EU and ISO 13485 : 2003, and other relevant regulatory bodies for the site.
Provide direct oversight to local manufacturing and laboratory system across multiple sites related to Change Control and System functionality.
Establish and manage system control oversight.
Serve as SME for electronic system compliance in support of inspection readiness activities.
Oversee investigation and corrective actions for non-conformances related to supplier quality, manufacturing and packaging, and support quality investigations outside of these areas as needed.
Work closely with site management, peers and colleagues to ensure that quality representation is activity engaged in facility and capital project initiation and execution.
Provide electronic system compliance expertise to the revision of the DH / DI standard and to provide recommendations regarding DH / DI training materials.
Ensure commissioning and validation activities are in-compliance with industry and site procedures.
Lead and participate in continuous improvement initiatives as appropriate. Managing the change control processes for the site.
Provide QA support of FDA or other regulatory inspections.
Ensure community of practice for DH / DI governance for electronic and hard copy data systems.
Support corporate initiatives as necessary.
Data Integrity Engineer - Quality Operations
Oversee investigation and corrective actions for non-conformances related to supplier quality, manufacturing and packaging, and support quality investigations outside of these areas as needed. Work closely with site management, peers and colleagues to ensure that quality representation is activity e...
Data Integrity Engineer - Quality Operations
Oversee investigation and corrective actions for non-conformances related to supplier quality, manufacturing and packaging, and support quality investigations outside of these areas as needed. Work closely with site management, peers and colleagues to ensure that quality representation is activ...
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