Job Purpose

This position will contribute to ensure that performance of manufacturing, packaging operations and product quality are aligned with GMPs to ensure lasting customer satisfaction. This individual will demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented.

Key Responsibilities

• Perform Quality Assurance activities associated with maintaining internal Quality Systems: Technical complaints, Change controls, CAPAS, Deviations, etc.
• Management of APQR reports:
• Act as APQR lead coordinating inputs from the different Product Supply areas.
• Lead the APQR subsystem in the integral forum.
• Review GMP technical and validation reports:
• Manufacturing and packaging processes.
• Computer/Automated systems involved in testing, manufacturing or materials control.
• Cleaning Validation/Equipment c...