Lead GMP QMS and Batch Release Consultant

Weil Group, Inc.; Puerto Rico; Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Weil Group Inc. in Manatí, Puerto Rico seeks an experienced consultant to lead an independent pharmaceutical quality-system assessment for a proposed GMP project.

You will review batch records, disposition criteria, deviations and CAPA, and deliver a practical remediation roadmap with an executive readout to stakeholders.

Qualifikationen

• Typically 10+ years of pharma quality-system experience.
• Experience reviewing batch dossiers and disposition criteria.
• Ability to map findings to FDA, EU GMP, and internal standards.

Aufgaben

• Lead the independent quality-system assessment.
• Review batch records, criteria, deviations, CAPA and change controls.
• Deliver remediation roadmap and executive readout.

Kenntnisse

Quality assessment

Regulatory mapping

Cross-functional leadership

English proficiency

Ausbildung

Science/Engineering/Pharmacy degree

Jobbeschreibung

Weil Group Inc. | Manatí, Puerto Rico | Project-based consulting

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.

Lead an independent pharmaceutical quality-system assessment and determine whether the records and controls supporting batch disposition are complete, consistent and defensible.

What you will do

• Direct the assessment plan, sampling approach, multidisciplinary team and technical conclusions.
• Review batch records, release criteria and interactions with deviations, CAPA, change control, complaints and product quality review.
• Integrate evidence-based findings, a practical remediation roadmap and an executive readout.

Mandatory requirements

• Personally led a comparable pharmaceutical or biologics GMP quality-system or batch-release assessment, with a verifiable individual contribution.
• Hands-on experience reviewing complete batch dossiers and Quality review, approval and disposition criteria.
• Ability to map findings to applicable FDA requirements, EU GMP and internal quality standards, distinguishing regulations, guidance and procedures.
• Direct experience with deviations, OOS or atypical results, CAPA and assessment of potential impact on other batches.
• Ability to defend evidence, risk classification and practical recommendations before senior Quality and operations stakeholders.
• 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 10 or more years of directly relevant professional experience, or a demonstrably equivalent track record.
• Apply quality risk management and pharmaceutical quality-system principles to practical improvements and effectiveness criteria.
• Lead cross-functional teams, define risk-based samples and document the scope and limits of conclusions.
• Relevant education in science, pharmacy, engineering or quality, or a demonstrated equivalent professional track record.

Desired qualifications

• Experience with the product types and manufacturing technologies ultimately included in the project.
• Regulatory audits, inspection readiness or quality assessments for multinational pharmaceutical manufacturers.
• Quality-auditing credentials, advanced pharmaceutical quality training and working Spanish.

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