Independent Senior GMP Technical Reviewer

Weil Group, Inc.; Puerto Rico; Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Job summary

Weil Group Inc. in Puerto Rico is seeking qualified consultants for a project-based pharmaceutical manufacturing quality-system assessment. You will independently challenge technical support, risk classification and material assessment findings before reports and recommendations are finalized.

Responsibilities include reviewing sampling coverage, evidence, references, and ensuring conclusions are feasible. On-site work in Manatí with approved remote options is required where applicable.

Qualifications

• Verifiable senior experience in QMS, GMP-record or batch-release assessments.
• Independence from authorship and client controls.
• Ability to challenge evidence, references and severity clearly.
• Professional English for technical records and discussions.
• On-site work in Manatí, Puerto Rico with approved remote work where appropriate.
• Commitment to confidentiality and information handling.

Responsibilities

• Review sampling coverage, evidence and limits of conclusions.
• Challenge findings for consistency and feasibility.
• Document review comments and unresolved material differences before final reporting.

Skills

QMS experience

GMP assessments

Independence

Challenge evidences

Professional English

On-site PR

Confidentiality

Education

Quality/Science or Eng education

Job description

Weil Group Inc. is identifying qualified consultants for a proposed pharmaceutical manufacturing quality-system assessment. This project-based opportunity is subject to project award and client confirmation.

Independently challenge the technical support, risk classification and practicality of material assessment findings before reports and recommendations are finalized.

What you will do

• Review sampling coverage, evidence, applicable references and limits of conclusions.


• Challenge material findings and recommendations for consistency and feasibility.


• Document review comments and unresolved material differences before final reporting.

Mandatory requirements

• Verifiable senior experience in QMS, GMP-record or batch-release assessments relevant to pharmaceutical or biologics manufacturing.


• Independence from authorship of the findings reviewed and from the client controls being assessed.


• Ability to challenge evidence, references and severity and document technical differences clearly.


• 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 12 or more years of directly relevant professional experience, or a demonstrably equivalent track record.


• Exercise regulatory judgment and recognize sampling and evidence-access limitations.


• Evaluate recommended actions and effectiveness or closure criteria.


• Relevant quality, science or engineering education or equivalent senior compliance experience.

Desired qualifications

• Technical review of consulting reports or corporate GMP audits.


• Relevant interaction with regulatory authorities and applicable auditing credentials.


• Experience with the confirmed product type and working Spanish.

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