Data Integrity & Risk Assessment Lead Lazio

Data Integrity & Risk Assessment Lead
Roma
Lazio, Lazio

_When joining Thermo Fisher Scientific, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer in mind.

The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions.

As the world leader in serving science and with the largest investment in R&D in the industry, our employees are empowered to realize their full potential.

You can become part of a fast-growing, global organization that values your passion and outstanding contributions.

Our dedication to you and our 80, 000 colleagues is to provide the resources and opportunities needed to make a difference in our world while building an exciting career with us. _

**Location**: Ferentino (FR)

**What will you do?

- Ensures data integrity practices and procedures are implemented and adhered to for quality compliance and to meet industry standards.

Establishes operational objectives and assists with developing, modifying, and implementing company policies.

- Ensures all new and existing equipment and systems are assessed appropriately and validated for its intended use and existence.

Coordinates procedure/process testing and provides reviews of audit trails.

- Provides gap assessments and status updates to senior management to maintain and improve data integrity.

Conducts monthly DI surveillance, provides weekly DI awareness, and reports findings to SLT

- Supports generation of risk assessments to identify high risk equipment/systems and implementation of appropriate corrective action.

- Leads site data integrity governance, departmental data integrity training for all lab / production operations, ensuring awareness and compliance with data integrity for both paper and electronic records, and good documentation practices.

- Develops, owns, and updates procedures as vital to ensure there is clear direction and understanding regarding awareness, responsibilities, and the importance of corporate and regulatory requirements for data integrity compliance.

- Supports creation and execution of change controls and establishes user requirements for laboratory and operations equipment.

- Ensures all software used for the generation of current Good Manufacturing Practices (cGMP) meets the standards required for data integrity compliance.

- Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.

Maintains the vital compliance status required by company and facility standards.

- Guarantee a detailed approach to quality risk management for Quality function purpose, using tools that enable effective and consistent risk based decisions.

**Education

- Bachelor's degree in engineering or biological sciences or related technical field.

**Experience

- At least 7 years experience in a regulated industry or 5 years with related technical knowledge including data integrity related to data from quality control testing, chromatographic systems, laboratory metrology, instrumentation compliance, manufacturing equipment and systems.

- Strong interpersonal skills and ability to work cross functionally with a diverse group of individuals to keep to timelines and meet internal/external commitments

- Strong writing and record keeping

- Project Management and/or prior management experience preferred.

**Knowledge, Skills, Abilities

- Strong knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).

- Experienced knowledge of laboratory instrumentation and/or operations equipment.

- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).

- Effective written, interpersonal, and presentation skills.

- Ability to work on multiple projects simultaneously.

- Ability to drive functional, technical and operational excellence.

- Ability to inspire and further innovation, teamwork, transparency and team effectiveness.