QMS SME: GMP Compliance & Batch Release Expert

Pinnaql, Inc.

Puerto Rico

On-site

USD 90,000 - 130,000

Full time

6 days ago

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Job summary

Validation & Engineering Group, Inc. seeks a Quality Management System (QMS) SME to lead an end-to-end QMS review across GMP records, data integrity, and batch-release processes for FDA/EU-regulated environments.

The ideal candidate has 6+ years in pharmaceutical, biotechnology, or medical device manufacturing, is fully bilingual in English and Spanish, and is able to work on-site in Manatí, Puerto Rico. You will inventory records and system interfaces (ERP/MES/LIMS/eQMS), assess data integrity

Qualifications

Bachelor's Degree in Engineering.
Minimum of 6 years in pharmaceutical, medical device, or biotechnology industries.
Experience in direct process/manufacturing areas.
Fully bilingual English/Spanish with excellent oral skills.
Proficient with MS Windows and Microsoft Office applications.
Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
Proven experience delivering QMS, data integrity, and batch-release assessments in FDA- and EU-regulated pharmaceutical, biologics, or medical-device manufacturing environments
Demonstrated expertise in GMP records management, computerized system interfaces (ERP/MES/LIMS/eQMS), and materials traceability / lot genealogy
Personnel with relevant regulatory and quality credentials and hands-on operational experience.
Ability to work on-site at Manatí, Puerto Rico.
Available to work extended hours, possibility of weekends and holidays.

Responsibilities

End-to-End QMS Review: map end-to-end quality system from creation to archival.
Review core QMS elements and interactions (deviation/CAPA, change control, document control, complaint handling, and product quality review).
Assess alignment of current-state processes with the BMS QMS Standard and applicable regulations (FDA, EU GMP, ICH Q7/Q9/Q10).
GMP Records & System Interfaces: inventory GMP records and systems (ERP/MRP, MES, LIMS, QMS/eQMS, WMS, and equipment/automation).
Map interfaces and data hand-offs between systems, including manual transcription steps.
Evaluate data integrity and ALCOA+ compliance across records and interfaces, including audit trails and review-by-exception practices.
Identify single points of failure and gaps that could affect release package accuracy.
Materials Traceability Review: assess end-to-end traceability from incoming inspection to finished goods; evaluate forward/backward traceability.
Ensure lot genealogy, material status control, segregation, and reconciliation of quantities; recommend automated controls where needed.
Batch Release Process Robustness: review batch record review and disposition workflow end-to-end; verify evidence for release decisions.
Assess quality review of data supporting batch disposition, ensuring completeness, accuracy, and cross-checking before release.
Benchmark against QMS standards and industry best practices; recommend enhancements for a robust release process.
Gap Analysis, Recommendations, and Roadmap: document findings in a risk-ranked gap analysis; provide prioritized recommendations and an implementation roadmap.