Senior QA & Compliance Analyst – TPM & GMP

Pinnaql; Humacao (PR); On-site; USD 120,000 - 150,000; Full time

Job summary

Validation & Engineering Group is seeking a Senior Product Quality Assurance (PQA) Analyst to support TPM plants, review investigations, approve manufacturing directions, and drive CAPA and annual Product Quality Reviews.

The role requires collaboration with regulatory teams, QA Operations, and TPM sites, with emphasis on cGMP compliance and change control; extended hours may be required.

Qualifications

• Bachelor's degree in Engineering or Science is required.
• Strong knowledge of GMP regulations affecting pharmaceutical products.
• Experience with CAPA, investigations, and change control is preferred.

Responsibilities

• Maintains liaison with Quality, Regulatory, Technical, and Supply Chain teams.
• Ensures TPM production complies with cGMP and QA directions.
• Reviews and approves manufacturing directions to production floor.
• Supports global projects, risk analysis, and implementation.
• Performs product quality reviews and trend analyses.
• Participates in Change Review Boards and TPM-related governance.

Skills

GMP knowledge

Analytical skills

Regulatory liaison

Cross-functional communication

Quality trending

Education

Bachelor's degree in Engineering or Science

Tools

SAP

LRMS

Job description

Validation & Engineering Group is seeking a Senior Product Quality Assurance (PQA) Analyst to support TPM plants, review investigations, approve manufacturing directions, and drive CAPA and annual Product Quality Reviews.

The role requires collaboration with regulatory teams, QA Operations, and TPM sites, with emphasis on cGMP compliance and change control; extended hours may be required.