Descripción del Trabajo
The Microbiologist Quality Engineer is responsible for the micro/bioburden and environmental monitoring (EM) management program in Jabil Waterford. The main duties of the role include performing monthly environmental monitoring in accordance with cGMP principles, managing micro excursion events internally and with the customer, micro data analysis and reporting as well as supporting and leading GMP training activities in relation to bioburden. Acts as Jabil Waterford’s quality contact for all micro/bioburden issues at the site
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Creates/maintains all site procedures in relation to micro/EM
- Understands and executes risk management practices in relation to EM
- Identifies and manages the resolution of excursions in bioburden/micro at the site
- Liaises with suppliers on their bioburden controls
- Acts as the Jabil lead for customer issues on bioburden
- Acts as chief auditee on all external audits in relation to EM and site contamination control strategy
- Contributes to the GMP training program and delivers training as appropriate
- Ensure the quality and production documentation is suitable in design for bioburden control
- Supports all company Lean Manufacturing principles
- Ensures compliance with all company policies and practices in areas such as safety and all regulatory compliance
- Supports all company quality programs and initiatives
- BSc Degree in Microbiology (or similar) discipline.
- Several years experience in a micro role (preferably Medical Device/Pharmaceuticals manufacturing)
- Organisational and planning skills are required to plan, execute and track quality commitments
- Working knowledge of ISO 13485 &/or Pharmaceutical EU GMP (Eudralex Volume 4)
- Excellent accuracy and attention to detail
- Excellent IT, communication and interpersonal skills to communicate well, both verbally and in writing.
- Ability to work off own initiative and as part of a cross functional team
- Desire to learn new tasks and flexibility