Data Integrity Steward

2 weeks ago

Greenville, United States Bausch & Lomb Full time

**Data Integrity Steward**

**Location:** US-SC-Greenville, South Carolina, US **Purpose of the Job**

The Data Integrity Steward is responsible for developing, implementing, and managing Greenvilles Data Integrity program. The Data Integrity Steward leads the GMP data integrity program both for electronic and paper-based programs and ensures compliance with the global and regulatory data integrity requirements.

**Key Activities**

Identify, develop and implement best Data Integrity practices and systems working cross-functionally throughout the organization:

Develop and implement data integrity procedures and processes

Develop data integrity training programs

Responsible for ensuring systems comply with data life cycle requirements from initial data creation/recording to archival and decommissioning. This includes, but is not limited to data management, user access, data review and reporting, archival and back-up, and data audit trails

Ensures proper system and application administrators are assigned and acts as system administrator when appropriate

Responsible for leading data integrity periodic reviews and performing risk monitoring of implemented systems to ensure continued compliance

Responsible for leading mitigation and remediation strategies when data integrity gaps are identified including associated CAPAs

Serves as the data integrity SME when sourcing and implementing new software solutions

**Qualifications**

Education: BS in Scientific discipline with IT background desired.

Experience:

-Minimum 5 years of GMP experience in a pharmaceutical/medical device industry

-Strong understanding of Pharmaceutical / Medical Device GMPs and Quality System Regulations and current industry practice, with emphasis in computer system validation and data integrity principles

-Expertise in good documentation practices

-Experience with document and data management systems

Preferred Skills: Strong organizational and communication skills required in order to develop programs, work independently with minimal supervision and effectively interact with all levels of the organization. Excellent time management skills. Demonstrated technical writing and proficiency with a variety of software applications.

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