Job Description
The Quality Engineer Production Support is responsible for generating investigation reports and addressing CAPAs (Corrective and Preventative Action) to ensure continuing production, resolution of manufacturing incidents, and optimization of operational activities for sterile injectable products.
The incumbent will leverage the site cross-functional team members to support these activities and work closely with the site operations and operational support departments (Engineering/Validation/QA/R&D) teams on-site.
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Key Responsibilities:
* Develop familiarity with site processes & procedures supporting GMP production of sterile injectable products.
* Initiate and complete non-conformance reports (NCRs) as required, coordinating production related NCRs to close in a timely manner.
* Develop CAPAs that satisfactorily address root cause and follow through on effective corrective actions to prevent reoccurrence of failures.
* Define/Develop Standard Operating Procedures & batch paperwork for equipment/processes in collaboration with Production personnel that incorporates Operational Excellence principles.
* Ensure that work is carried out safely and in compliance with the organization's quality system.
* Learn how to generate quality documentation in compliance with the internal organisational procedures and GMP.
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