Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Quality Management System (QMS) SME
Description:
End-to-End QMS Review
- Map the end-to-end quality system as it relates to GMP record creation, review, approval, and archival
- Review core QMS elements and their interactions, including deviation/CAPA management, change control, document control, complaint handling, and product quality review
- Assess alignment of current-state processes and procedures with the BMS QMS Standard and applicable regulations (FDA, EU GMP, ICH Q7/Q9/Q10 as relevant)
GMP Records and System Interfaces
- Inventory the GMP records (electronic and paper/hybrid) and the systems that generate, store, or consume them (e.g., ERP/MRP, MES, LIMS, QMS/eQMS, warehouse management, and equipment/automation systems)
- Map the interfaces and data hand-offs between these systems, including any manual transcription, reconciliation, or bridging steps
- Evaluate data integrity and ALCOA+ compliance across these records and interfaces, including audit trail adequacy and review-by-exception practices
- Identify single points of failure, redundant or conflicting records, and reconciliation gaps that could affect the completeness or accuracy of the release package
Materials Traceability Review
- Assess end-to-end traceability of materials: incoming inspection and acceptance, warehousing, dispensing/kitting, in-process consumption, component/subassembly linkage, packaging, and finished-goods
- Evaluate forward and backward traceability (i.e., the ability to trace any material to all finished lots, and any finished lot back to all constituent materials, equipment, and records)
- Review controls for lot genealogy, material status control, segregation, and reconciliation of quantities
- Identify where traceability relies on manual controls and recommend system-based or automated controls to close those gaps
Batch Release Process Robustness and Quality Data Review
- Review the batch record review and disposition workflow end to end, including the criteria and evidence relied upon for the release decision
- Assess the quality review of data supporting batch disposition — the completeness, accuracy, and integrity of the records and system data reviewed, and how they are verified, reconciled, and cross-checked prior to release
- Evaluate the adequacy, consistency, and defensibility of the review process, including review-by-exception practices and the handling of discrepancies, exceptions, and out-of-specification/atypical results
- Benchmark the process against the QMS Standard and industry good practice, and recommend enhancements to ensure a robust, right-first-time release process
Gap Analysis, Recommendations, and Roadmap
- Document all findings in a risk-ranked gap analysis, mapped to the relevant regulation and QMS Standard clause
- Provide prioritized recommendations distinguishing immediate/quick-win actions from medium- and long-term remediation
- Deliver an implementation roadmap with suggested sequencing, dependencies, and indicative effort/resource considerations
Qualifications:
- Bachelor's Degree in Engineering.
- Minimum of 6 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Experience in direct process / manufacturing areas.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Must be proficient using 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.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.