Our team is committed to empowering people worldwide to live healthier at every stage of life.
The Role
A Quality Engineer in Production Support plays a vital role in generating investigation reports and addressing Corrective and Preventative Actions (CAPAs) to ensure continuing production, resolution of manufacturing incidents and optimization of operational activities for sterile injectable products.
* Develop familiarity with site processes & procedures supporting Good Manufacturing Practice (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.
Every day, we strive to make a difference and here's how the Quality Engineer in Production Support role will contribute:
• Ensure work is carried out safely and in compliance with our quality system.
• Learn to generate quality documentation in compliance with internal organisational procedures and GMP.
• Take ownership and ensure all personally assigned duties are carried out and controlled in line with internal organisation's policies.
• Support operations area projects and initiatives when required.
About Your Skills & Experience
We're seeking a candidate with an effective combination of the following qualifications, skills and experiences:
* A good understanding of pharmaceutical production and GMP.
* Degree/Diploma in relevant Science/Engineering/Manufacturing/Pharmaceutical course.
* Good communication and interpersonal skills.
* Good report writing skills.
* Good analytical skills with excellent attention to detail.
* The ability to work independently, be proactive with a solutions-driven approach.