When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
 
Location/Division Specific Information
Greenville, NC | Drug Product Pharma Services Group
 
How will you make an impact?
As the sites Data Integrity Compliance Officer, you will be responsible for compliance of all new and legacy equipment and instrumentation to all applicable regulations, both external and internal (21 CFR Part 11, Annex 11, ICH Guidances, Global Standards, Local SOPs, etc).  The individual will be tasked with supporting the site, and leading initiatives with respect to data management, governance, issue resolution and quality. 
 
 
What will you do?              

• Ensures all new and legacy equipment and instrumentation is assessed appropriately and validated for its intended use, with respect to Data Integrity and compliance with cGMP requirements.
• Thorough understanding and application of 21 CFR Part 11, Annex 11, ICH, MHRA and WHO Guidances on DI.
• Assesses technical responses to questions/issues raised by internal/external customers, regulatory agencies, etc and serves as the sites Data Integrity SME.
• Communicates actions, compliance gaps, and commitments to respective areas, including the Site Director of Quality.
• Creates/updates procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations.  Routinely evaluate regulatory inspection documents and keep the site aware of trends.
• Leads the Site Data Integrity Governance Team meetings, provides assessments and status updates to aid Data Integrity Governance team’s actions to maintain and proactively improve data integrity.

• Bachelor’s degree in Chemical / Biological Science, Engineering, or a related field.

• Must have at least 10 years experience in the Pharmaceutical Industry.  Knowledge of manufacturing data, QC data, instrumentation and associated computer systems and TrackWise.  Supervision or Management experience are a plus.