Senior GMP Data Integrity and Computerized Systems Compliance Consultant

Weil Group, Inc; Manatí (PR); On-site; USD 100,000 - 140,000; Full time

Job summary

Weil Group Inc. seeks a Senior GMP Data Integrity and Computerized Systems Compliance Consultant to perform a targeted, on-site assessment in Manatí, Puerto Rico, with remote work options where appropriate.

The consultant will review GMP records and metadata, audit trails, access controls, and electronic signatures, delivering evidence-based findings and feasible quality-controls. Required are hands-on experience with GMP records in pharma/biologics, knowledge of 21 CFR Part 11 and EU GMP Annex

Qualifications

• Hands-on assessment of GMP records and metadata in pharma/biologics operations.
• Review of audit trails, user access, attribution, changes and electronic signatures.
• Assess 21 CFR Part 11 and EU GMP Annex 11 with GMP record requirements.
• Experience with manufacturing or laboratory systems linking records to Quality processes.
• Identify incomplete records, unreconciled transcription and review-by-exception limitations.
• Professional English for technical records, deliverables and stakeholder discussions.
• On-site work in Manatí, Puerto Rico, with approved remote work where appropriate.
• Confidentiality, site and information-handling requirements and conflicts disclosure.

Responsibilities

• Review original electronic, paper and hybrid records and relevant metadata.
• Evaluate audit trails, access, changes, electronic signatures and data review practices.
• Develop evidence-based findings and feasible controls with Quality, Laboratory, Manufacturing and IT.

Education

Education in quality/pharma/engineering/computerized-system compliance

Job description

Senior GMP Data Integrity and Computerized Systems Compliance Consultant

• Manati, PR
• Biotech/Pharmaceutical

Weil Group Inc. is identifying qualified consultants for a proposed pharmaceutical manufacturing quality-system assessment. This project-based opportunity is subject to project award and client confirmation. Assess whether GMP records preserve their content, context, integrity and traceability throughout creation, review, transfer, retention and use in Quality decisions.

What you will do

• Review original electronic, paper and hybrid records and relevant metadata.
• Evaluate audit trails, access, changes, electronic signatures, review practices and record retention.
• Develop evidence-based findings and feasible controls with Quality, Laboratory, Manufacturing and IT.

Mandatory requirements

• Hands-on assessment of original GMP records and metadata in pharmaceutical or biologics operations.
• Practical review of audit trails, user access, attribution, changes, electronic signatures and data review before release.
• Ability to assess applicability and controls under 21 CFR Part 11 and EU GMP Annex 11 together with the underlying GMP record requirements.
• Experience with manufacturing or laboratory systems and the connection of their records to Quality processes.
• Ability to identify incomplete records, unreconciled transcription and limitations in review-by-exception practices.
• Professional English for technical records, deliverables and stakeholder discussions.
• Availability for assigned on-site work in Manatí, Puerto Rico, with approved remote work where appropriate.
• Ability to meet confidentiality, site and information-handling requirements and disclose potential conflicts affecting independent assessment.

Necessary qualifications

• Typically 7 or more years of directly relevant professional experience, or a demonstrably equivalent track record.
• Evaluate validated state, change control, incidents, periodic review, retention, recovery and supplier controls.
• Design risk-based audit-trail review criteria and workable controls for hybrid records.
• Relevant education or equivalent practical experience in quality, pharmaceutical science, engineering or computerized-system compliance.

Desired qualifications

• Experience across both laboratory data and electronic manufacturing records.
• GAMP, system-auditing or data-integrity training; experience with the platforms confirmed for the project.
• Participation in data-integrity improvements with measured outcomes and working Spanish.

Weil Group is proud to be an Equal Employment Opportunity Employer.