The Quality Engineer Production Support role is responsible for generating investigation reports and addressing CAPAs (Corrective and Preventative Action) to support continuing production, resolution of manufacturing incidents and optimization of operational activities for sterile injectable products.
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The incumbent will leverage the site cross-functional team members to support these activities and work closely with the site operations and operational support departments teams on-site.
Key Responsibilities:
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* Develop 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.
* Develop CAPAs that satisfactorily address root cause and following 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. Learn how to generate quality documentation in compliance with the internal organisational procedures and GMP.
* Take ownership and ensure all personally assigned duties are carried out and controlled in line with the internal organization's policies.
* Support operations area projects and initiatives when required.
Required Skills and Qualifications:
* A good understanding of pharmaceutical production and GMP, prior 'hands-on' experience would be a distinct advantage.
* 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.
* Have the ability to work independently, be proactive with a solutions driven approach
* Knowledge in Electronic Records system (Specifically digital Quality Management Systems), Process improvement/design is desirable but not required
* Knowledge of DMAIC/Problem solving tools and Lean Principles is desirable but not required
Why Viatris?
Viatris offers competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help 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.
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve.