About Us
We are seeking a skilled Quality Engineer Production Support Specialist to join our team in the production of sterile injectable products.
The Role:
This position will be responsible for generating high-quality investigation reports and implementing Corrective and Preventative Actions (CAPAs) to ensure continued production and resolve manufacturing incidents.
Responsibilities:
* Develop and maintain site processes & procedures that support Good Manufacturing Practices (GMP)
* Initiate and complete non-conformance reports (NCRs) as required, ensuring timely closure of production-related NCRs
* Develop CAPAs that effectively address root causes and implement corrective actions to prevent reoccurrence of failures
* Create Standard Operating Procedures & batch paperwork for equipment/processes in collaboration with Production personnel, incorporating Operational Excellence principles
* Evaluate work performance and ensure compliance with the organization's quality system
* Provide training and support to colleagues on quality documentation and GMP guidelines
* Support operations area projects and initiatives as needed
About You:
To succeed in this role, you should have a strong understanding of pharmaceutical production and GMP principles. A degree/Diploma in relevant Science/Engineering/Manufacturing/Pharmaceutical course is desirable, but not essential. Prior 'hands-on' experience is an advantage, although full training will be provided.
Requirements:
* A good working knowledge of MS Office Suite
* Excellent communication and interpersonal skills
* Strong report writing skills
* Good analytical skills with attention to detail
* Able to work independently and proactively with a solutions-driven approach
Desirable Skills:
* Knowledge of Electronic Records systems (digital Quality Management Systems)
* Familiarity with process improvement/design and problem-solving tools (DMAIC/Lean Principles)