About Quality Engineers
The Quality Engineer Production Support role 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.
This position will make an impact by:
* Developing familiarity with site processes & procedures supporting GMP production of sterile injectable products.
* Initiating and completing non-conformance reports (NCRs) as required, coordinating production-related NCRs to close in a timely manner.
* Developing CAPAs that satisfactorily address root cause and following through on effective corrective actions to prevent reoccurrence of failures.
* Defining/Developing Standard Operating Procedures & batch paperwork for equipment/processes in collaboration with Production personnel that incorporates Operational Excellence principles.
* Ensuring that work is carried out safely and in compliance with the organization's quality system.
About Your Skills & Experience
We are looking for a candidate who has an effective combination of the following qualifications, skills, and experiences:
* A good understanding of pharmaceutical production and GMP, prior 'hands-on' experience would be a distinct advantage, however this is not a requirement as full training will be provided to the successful candidate.
* Degree/Diploma in relevant Science/Engineering/Manufacturing/Pharmaceutical course (e.g. Manufacturing, Mechanical, Biomedical, Pharmaceutical Operations, etc.), however a combination of relevant work experience and education will be considered.
* Must possess a good working knowledge MS Office Suite.
* Good communication and interpersonal skills
* Good report writing skills
* Good analytical skills with excellent attention to detail.