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Data Integrity Compliance Officer

Location Covingham, Swindon, Wiltshire, United Kingdom Job Id R-01296169 Job Type Full time Category Quality & Regulatory Remote Fully Onsite

The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.
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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Job Title: 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!

Accessibility/Disability Access
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
 
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EEO & Affirmative Action Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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"Quality is everyone's responsibility. Right the first time should not be only a metric, but a lifestyle."


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Director, Regulatory Affairs,
Latin America, Specialty Diagnostics

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