Quality Engineer Production Support Role Overview
The Quality Engineer Production Support is a critical role responsible for generating investigation reports, addressing Corrective and Preventative Action (CAPA), and supporting continuing production to ensure the highest quality standards are met.
As a key member of the site cross-functional team, this individual will work closely with operations and operational support departments to optimize operational activities and drive process improvements in sterile injectable products.
Key Responsibilities:
* Develop familiarity with site processes & procedures supporting Good Manufacturing Practice (GMP)
* 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
This role requires a good understanding of pharmaceutical production and GMP. Prior 'hands-on' experience is desirable but not required as full training will be provided to the successful candidate.
Required Skills & Qualifications:
To succeed in this role, the ideal candidate should possess:
* A degree or diploma in a relevant Science/Engineering/Manufacturing/Pharmaceutical course (e.g., Manufacturing, Mechanical, Biomedical, Pharmaceutical Operations)
* Good working knowledge of MS Office Suite
* Good communication and interpersonal skills
* Good report writing skills
* Good analytical skills with excellent attention to detail
* Ability to work independently, be proactive with a solutions-driven approach
Benefits:
We offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
Why Join Our Team?
We believe in healthcare as it should be – empowering people worldwide to live healthier at every stage of life. If you're passionate about making a difference, we encourage you to apply.