Senior GMP Systems Functional Consultant

Weil Group, Inc

Manatí (PR)

Ibrido

USD 90.000 - 150.000

Tempo pieno

2 giorni fa
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Descrizione del lavoro

Weil Group Inc. is seeking a Senior GMP Systems Functional Consultant to assess and optimize GMP platform configurations within pharmaceutical manufacturing quality systems.

The role focuses on validating platform behavior, traceability, and quality decisions while working closely with site stakeholders. Applicants should have deep experience with GMP platforms (ERP/MES/LIMS/eQMS), strong documentation skills in English, and willingness to work on-site in Manatí, Puerto Rico, with approved

Competenze

  • Hands-on experience with GMP platform and function.
  • Practical GMP experience with ERP, MES, LIMS or eQMS workflows.
  • Ability to trace system records, configuration and transactions and explain impact on the process.
  • Professional English for technical records and discussions.

Mansioni

  • Explain and assess the GMP platform configuration, transactions, status rules and workflows.
  • Link system behavior to material traceability and quality decisions.
  • Support platform-specific findings and improvement dependencies.

Conoscenze

Platform experience
GMP knowledge
Quality systems
English proficiency

Formazione

Pharma/Quality education

Strumenti

ERP
MES
LIMS
eQMS

Descrizione del lavoro

Senior GMP Systems Functional Consultant
  • Manati, PR
  • Biotech/Pharmaceutical

Weil Group Inc. is identifying specialists for potential assignments within a proposed pharmaceutical manufacturing quality-system assessment. This opportunity is subject to confirmed specialist scope, project award and client confirmation.

Provide deep functional expertise in the specific GMP platform and process assigned after the installed systems are confirmed.

What you will do
  • Explain and assess the relevant platform configuration, transactions, status rules and workflows.
  • Connect system behavior and validation evidence with material traceability or Quality decisions.
  • Support platform-specific findings and practical improvement dependencies.
Mandatory requirements
  • Hands-on experience in the specific platform and function assigned to the assessment.
  • Practical GMP experience with the relevant ERP, MES, LIMS or eQMS workflow.
  • Ability to trace system records, configuration and transactions and explain their impact on the assessed process.
  • 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.
  • Understand configuration, material or batch status rules, workflows and relevant validation documentation.
  • Work with platform owners and the integration and data-integrity specialists.
  • Relevant systems, engineering, pharmaceutical or quality education, or equivalent platform experience.
Desired qualifications
  • Experience in the version and deployment model actually installed at the site.
  • Comparable implementations and subsequent operational support.
  • Platform-specific training or credentials relevant to the assigned function.

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

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