Data Integrity Compliance Officer
As the world leader in serving science, our work is more than something that fills our days – what we do has great purpose. Our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research to clinical to commercial production means you can have a broad and meaningful impact here at Thermo Fisher Scientific. All while working in an environment where you will be supported, valued and rewarded for your performance.
Data Integrity Compliance Officer
Location: Swindon
Responsibilities:
- Establishes and chairs the Data Integrity Governance Team meetings.
- Assess and make sure all new equipment and instrumentation are validated for intended use, existence, usage, and review of audit trails and regulations.
- Provides assessments and status updates to aid Data Integrity Governance team’s actions to maintain and proactively improve data integrity.
- Ensures Governance Team deliverables are on target, accurately resourced and completed as committed.
- Communicates actions, compliance gaps, and commitments to respective areas, including the Site Director of Quality.
- 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.
- Updates procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations. Routinely evaluates regulatory inspection documents and updates site procedures accordingly. Keeps the Governance Team aware of industry trends.
- Assists in establishing user requirements for equipment.
- Meets with vendors to discuss software capabilities in regards to 21CFR Part 11 compliance.
- Establishes and leads a Surveillance program to audit all GMP facilities within the site.
- Assesses technical responses to questions/issues raised by regulatory agencies and customers. Serves as an advisor to Manufacturing/Quality Operations Division for Data Integrity matters.
Minimum Requirements/Qualifications:
Proficiencies:
- Solid knowledge of cGMP and cGDP.
- Experience in HPLC and GC data review, 21CFR Part 11 instrumentation compliance as well as writing and reviewing investigations within TrackWise.
- Previous supervision or management experience is preferred.
- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
- Effective written, interpersonal, and presentation skills.
- Ability to work on multiple projects simultaneously.
Qualifications/Experience:
- Bachelor’s Degree in Science, Engineering, or related fields, or equivalent experience.
- Required: Solid track record experience in a regulated industry. Must possess relevant technical knowledge, including data integrity related to quality control data from chromatographic systems. Also, knowledge of laboratory instrumentation and/or operations equipment and associated computer systems and TrackWise.
- Project Management, Supervision or Management experience are preferred.
At Thermo Fisher Scientific, each one of our 110,000 outstanding individuals has an unusual story to tell. Join us and contribute to our exceptional mission—enabling our customers to make the world healthier, cleaner and safer.
We offer a range of flexible benefits including Pension and Healthcare in addition to competitive salaries!
Work Schedule
- Standard (Mon-Fri)
Environmental Conditions
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
