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Qualified candidates must be willing to travel throughout the US and abroad up to 25% as required
Responsibilities:
- Perform data integrity assessments, deviation investigations, and support/perform data integrity remediations in CGMP operations both internal to Gilead and our global suppliers.
- Perform GxP applicability, part 11, and Data Integrity risk assessments (DIRA), detailed data integrity reports, and create executive summary reports.
- Collaborates with our global suppliers and/or Gilead sites to assess their DI maturity state and provide DI guidance and best practices to our global suppliers.
- Experienced in GMP requirements, data integrity, and quality trends (e.g., 21 CFR Part 11, 210, 211, 820).
- Work independently and successfully solve problems.
- Provide expertise and/or training in system qualification, application validation, and CFR21 Part 11/210/211/820, MHRA, and Annex 11 DI guidance, and regulatory compliance governing the pharma industry to our global suppliers and internal staff.
Qualifications:
- Bachelor's degree in scientific or engineering discipline along with 10 plus years of experience in the field of Data Integrity compliance and computer validation.
- Ideal candidate will have significant experience in pharma application systems supporting the labs and production such as Laboratory Information Management (LIMS), Electronic Lab Notebooks (ELN), document management, and quality systems.
- Experience in system qualification, application validation, regulatory compliance and internal requirements employing regulatory guidance and industry standards.
- Excellent verbal communication and technical writing skills.
- Extensive experience with all pertinent industry best practices (e.g., ISPE GAMP5) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, Delta V, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
- Working knowledge of the development of protocols for the validation of complex computer systems
- Significant experience using MS Office 365 suite of applications. (PowerPoint, Excel, Word, Project, etc.)
Job Type: Contract
Salary: Up to $90.00 per hour
Experience level:
- 11+ years
Experience:
- Data Integrity: 6 years (Required)
- GxP , part 11, and Data Integrity risk assessments: 10 years (Required)
- Data Integrity compliance and computer validation.: 9 years (Required)
- CFR21 Part 11/210/211/820, MHRA, and Annex 11 DI: 10 years (Required)
- URS, SRS, FRS, DDS, RTM, Unit: 10 years (Required)
- Delta V, FAT, SAT, Validation Planning, IQ, OQ,: 10 years (Required)
- (LIMS), Electronic Lab Notebooks (ELN): 10 years (Required)
Work Location: Remote
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