CSV and Data Integrity (DI) ConsultantApply Now
Location: Framingham, Massachusetts
Employment Type: Contract
Job Description
Contract Length: 12+ months
Job Summary: This person will lead data integrity initiatives and validation efforts for complex computerized systems.
Responsibilities:
Requirements:
Job Summary: This person will lead data integrity initiatives and validation efforts for complex computerized systems.
Responsibilities:
- Lead Data Integrity Assessments for systems across manufacturing, laboratory, and quality processes, identifying risks and implementing control measures.
- Develop Data Process Maps, Risk Assessments, and Audit Trail Review methodologies for computerized systems.
- Update and maintain SOPs, including Validation Master Plans and sub-VMPs, to reflect compliance with regulatory standards and data integrity requirements.
- Perform and document periodic reviews of systems, incorporating findings from data integrity evaluations and ensuring alignment with validation principles.
Requirements:
- Strong experience in CSV and data integrity compliance for manufacturing, laboratory, and quality systems.
- Expertise in regulatory requirements for data integrity, including FDA, EU Annex 11, and ALCOA+ principles.
- Proven ability to develop and maintain SOPs, validation plans, and risk assessments.
- Excellent analytical, documentation, and stakeholder management skills.
- Familiarity with a broad range of computerized systems supporting manufacturing and laboratory processes.
Contact
Christian Griffith
Principal Recruiter
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