Qms & Data Integrity Consultant – Gmp Systems & Batch Release

Senior QMS & Data Integrity Consultant – GMP Systems & Batch Release

Location: Puerto Rico – On-Site Support Required

Industry: Pharmaceutical / Biopharmaceutical Manufacturing

Project Type: Consulting Engagement

Position Summary

ProQuality Network is seeking a highly experienced Senior QMS & Data Integrity Consultant to support a comprehensive, end-to-end Quality Management System (QMS) assessment within a GMP-regulated pharmaceutical manufacturing environment.

The selected consultant will perform a hands-on evaluation of quality systems, GMP records, computerized system interfaces, materials traceability, and batch disposition/release processes. This role requires a senior-level Quality professional capable of evaluating how GMP information flows across manufacturing and quality systems, identifying compliance and operational gaps, and developing practical, risk-based recommendations.

This is not solely a desktop or procedural review. The consultant must be comfortable working directly with actual batch records, electronic systems, paper/hybrid records, and cross-functional site teams to evaluate how processes operate in practice. RFP_QMS_Assessment_V1

Key Responsibilities

Perform an end-to-end assessment of the site Quality Management System (QMS) and supporting GMP processes.
Evaluate GMP record creation, review, approval, reconciliation, and archival processes.
Assess key QMS elements, including Deviations, CAPA, Change Control, Document Control, Complaint Handling, and Product Quality Review.
Review electronic and paper/hybrid GMP records and evaluate interfaces across systems such as ERP/MRP, MES, LIMS, QMS/eQMS, warehouse management, and equipment/automation systems.
Assess Data Integrity and ALCOA+ compliance, including audit trails, data hand-offs, manual transcription, reconciliation, and review-by-exception practices.
Evaluate end-to-end materials traceability and lot genealogy, from incoming materials through manufacturing, packaging, and finished-product disposition.
Assess forward and backward traceability of materials, components, equipment, records, and finished lots.
Evaluate the robustness of batch record review, batch disposition, and product release processes.
Identify gaps, weaknesses, single points of failure, conflicting records, and areas dependent on manual reconciliation.
Conduct risk-based gap assessments against applicable GMP and regulatory requirements.
Develop practical, prioritized recommendations, including quick wins and medium- and long-term remediation strategies.
Collaborate directly with Quality, Manufacturing, IT/Automation, and other cross-functional stakeholders.
Support development of current-state process maps, gap assessments, remediation roadmaps, and executive-level findings/readouts. RFP_QMS_Assessment_V1

Required Qualifications

Extensive experience in Quality Management Systems (QMS) within FDA- and/or EU-regulated pharmaceutical, biotechnology, biologics, or medical device manufacturing environments.
Demonstrated hands-on experience with GMP records management, Data Integrity, and batch release/disposition processes.
Strong understanding of materials traceability and lot genealogy within GMP manufacturing operations.
Experience evaluating or working across computerized systems such as ERP, MES, LIMS, eQMS/QMS, warehouse management, and manufacturing/automation systems.
Strong knowledge of GMP requirements, ALCOA+ principles, and applicable FDA and EU GMP expectations.
Experience with quality systems including Deviations, CAPA, Change Control, Document Control, and Product Quality Review.
Ability to identify compliance and operational risks and translate findings into practical, implementable remediation actions.
Strong analytical, technical writing, communication, and stakeholder-management skills.
Ability to work independently and interact effectively with senior Quality leadership and cross-functional technical teams.
Availability to provide on-site support in Puerto Rico as required. RFP_QMS_Assessment_V1

Highly Desired Experience

Previous experience performing QMS assessments, compliance gap assessments, data integrity reviews, batch-release assessments, or remediation programs in regulated manufacturing environments is highly desirable.

Experience physically tracing batch records and material flows across multiple electronic systems and paper/hybrid records is particularly valuable for this engagement.

Regulatory / Technical Knowledge

Candidates should have strong working knowledge of applicable pharmaceutical quality and GMP frameworks, including:

21 CFR Parts 210 & 211 | EU GMP | ICH Q7/Q9/Q10 | Data Integrity / ALCOA+ | GMP Records | QMS | Batch Release & Disposition | Materials Traceability | Lot Genealogy | Deviations | CAPA | Change Control | ERP | MES | LIMS |