As a DI / CSV specialist, you will be working as part of the Quality Validation team strengthening the compliance of the quality system for all Data Integrity aspects including Computer systems validation.

Assists in DI / CSV improvement projects and acts as an SME regarding Data Integrity. The DI / CSV person will drive the improvement efforts and also be involved in all quality-related responsibilities for automation and Computerized System Validation (CSV ).

The DI / CSV specialist will work with cross-functional groups to build data integrity principles into paper-based and computer system-based life cycles. This role will work to get a deep understanding of the GMP Data Flows and apply data integrity principles to ensure regulatory compliance.

Key responsibilities:

· Support operations and projects for Data Integrity Requirements to align with overall data integrity governance

· Be a Subject Matter Expert and provide technical support for all aspects of Data Integrity supporting CSV activities

· Oversee and guide operations and projects in aspects of Data Integrity

· Complies with GMP regulations with a focus on data integrity. Performs activities required to mitigate any compliance gaps identified

· Support data integrity training content/tracking and training for site personnel

· Collaborate in the gathering, tracking, and reporting of data integrity metrics

· Collaborate with cross-functional teams on aspects of Data Integrity

· Support mitigation and remediation efforts for data integrity compliance across the site

· Perform, facilitate, and support data integrity improvements for documents, processes, and equipment

· Review and approve validation documentation, risk assessments, and support in site compliance activities

· Responsible for ensuring the Data Integrity Compliance of standard operating procedures and work instructions across the site

· Support the change control process with respect to the data integrity impact, able to assess the change controls with respect to data integrity

· Participate in deviations related to data integrity

· Experience with Current Good Manufacturing Practices and Good Documentation Practices

· Participate in gap assessments to ensure regulatory findings at the company and in the industry are monitored and corrected.

· Support quality-related responsibilities for automation and Computerized System Validation (CSV)

· Representing Quality in the respective global standards definition and implementation.

Key requirements:

· Bachelor in Science or Engineering

· Highly Experienced with Data Integrity principles and their implementation

· Strong experience within Computerized Systems Validation (CSV) and 21 CFR Part 11

· Experienced within the Biopharmaceutical industry is required

· Ability to work effectively as part of the team and independently with limited direction

· Good knowledge of regulations and guidance, including but not limited to 21 CFR Parts 210, 211, EU Annex 11, GAMP 5, and ISO 13485:2003 requirements

· Proficient in Good Documentation Practices

· Thorough knowledge of validation life cycle for Computer Systems/Software

· Proficient in the use of spreadsheets, databases, and word processing software.

· Performs statistical analysis of data a plus.

· Thorough knowledge of laboratory and manufacturing equipment.

· Proficient in performing equipment and process risk assessments using FMEA/PFMEA analysis.

· Knowledge of SAP and TrackWise systems a plus.

· Uses experience and knowledge to solve problems, make decisions, and develop plans for the group. Makes recommendations for the department.

· Able to identify and respond to complex problems, interpret complex data, and draw valid conclusions.

· Able to write complex procedures and reports.

· Able to communicate status, needs, forecasts, risks, and timelines effectively to management.

· Ability to work and communicate in a team environment.

· Must possess the capability to work in a fast-paced environment with cross-functional teams