Data Integrity Compliance Specialist Monza

Data Integrity Compliance Specialist
Monza
Lombardia, Monza

Role Summary

In this role you will ensure the adoption of Data Integrity principles and guidelines and promote a culture of continuous improvement.

As Data Integrity Compliance Specialist you will act as the SME during regulatory audits for Data Integrity and customer audits to answer questions and demonstrate to auditors that necessary controls and required competencies are in place.

In this position will closely interact with experienced personnel from operations and/or computer system operations and you will play a key role in supporting the site's growth.

**Main Activities

- Member of the Data Integrity Governance Team meetings.

- Assess and review all new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage, and review of audit trails and 21CFR Part 11 and Annex 11 regulations.

- Executes assessments and status updates to aid Data Integrity Governance team's actions to maintain and proactively improve data integrity.

- Support the Governance Team deliverables and requests.

- Communicates/escalates actions, compliance gaps, and commitments to respective areas, including the Data Integrity & Quality Risk Manager;

- Performs risk assessments to determine high risk equipment and audit trails and take appropriate action to bring into compliance.

- Assist in sourcing, assessing, and recommending instrumentation/equipment for purchase.

- Provides periodic training to all operations to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practices.

- Review and support execution of Change Controls for instrumentation/equipment new implementation and upgrade to cover DI matters.

- Facilitate discussion with vendors and relevant functions about software capabilities in regards to 21CFR Part 11 compliance.

- Execute DI Oversight into the GxP relevant are, it includes Quality, Manufacturing, QC areas;

- Support the Data Integrity & Quality Risk Manager to coordinate the DI Governance team in setting priorities and project assignments;

- Assesses/executes technical responses to questions/issues raised by regulatory agencies and customers;

- Collaborates on projects to meet customer, business, and regulatory requirements for Data Integrity matters.

**REQUIREMENTS

**Education

- Bachelor's Degree in Science, Engineering, or related fields

**Technical Skills

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

- Experience 21CFR Part 11/Annex11 instrumentation compliance as well as writing and reviewing investigations within TrackWise.

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

**Professional Background

- Must have at least 3 years experience in a regulated industry including data integrity related to quality control data from lab systems and manufacturing Systems, knowledge of laboratory instrumentation and/or operations equipment and associated computer systems and TrackWise.

- Project Management, Supervision or Management experience are preferred.

**Languages

- English, Italian (fluent)

**Personality Traits

- Accountability and proactivity

- Team work player

- Listening, negotiation and communication skills

- Pragmatic and oriented to results achievement