Senior GMP Data Integrity & CS Compliance Consultant

Weil Group, Inc

Manatí (PR)

On-site

USD 100,000 - 140,000

Full time

2 days ago

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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.