QA Specialist: NPI, Validation & FAT in Manufacturing

Mirus Consulting Group

Juncos (PR)

Sur place

USD 60 000 - 90 000

Plein temps

Il y a 3 jours

Soyez parmi les premiers à postuler

Obtenez une réponse de cet employeur

Votre CV et votre lettre de motivation, adaptés exactement à ce que l’employeur recherche.

Passez les filtres ATS

Résumé du poste

mîrus Consulting Group is seeking a Specialist QA to support quality assurance activities for manufacturing and new product implementation projects. The ideal candidate will have experience in New Product Introduction (NPI), Change Control, Factory Acceptance Testing (FAT), Validation, and Process Performance Qualification (PPQ) within a regulated environment.

The role involves collaborating with Manufacturing, Engineering, Validation, and Operations to ensure regulatory compliance and quality

Qualifications

Experience with quality assurance activities in manufacturing and product introduction.
Knowledge of regulatory requirements and GMP/quality standards.

Responsabilités

Support and oversee New Product Introduction (NPI) activities to ensure compliance with quality requirements.
Manage and review Change Control processes and associated documentation.
Participate in and support Factory Acceptance Tests (FATs) for new equipment and systems.
Review, execute, and approve validation protocols and reports.
Support Process Performance Qualifications (PPQs) and related quality activities.
Ensure compliance with applicable regulatory requirements, quality standards, and company procedures.
Collaborate with cross-functional teams including Manufacturing, Engineering, Validation, and Operations.