Develop and revise systems within the Quality Management System (QMS) to ensure further process improvements to the existing system
Carry out quality reviews such as annual product reviews
Originate documents to support release and shipping of products
Develop, maintain KPIs for QMS system
Author and review specifications for medicinal products
Aid in the implementation of new documents within the QMS
Participate in training program to ensure proficiency to work within the Quality system.
Periodically update the QA Director on progress
Involvement in project work as needed
- Relevant academic qualification (Science)
- Relevant experience working in the pharmaceutical or biotechnology industry
- Experience in GMP/GDP QMS
- Experience in manufacture and release of various dosage forms of both commercial and investigational medicinal product (small and large molecule)
- Excellent relationship management skills
- Strong project management skills, with a keen desire for execution
- Strong analytical and strategic thinking abilities
- Strong organizational skills, including ability to follow assignments through to completion
- Requires a proactive approach and excellent written/oral communication and interpersonal skills.
- Strong interpersonal skills required to interact management and peers effectively. Effective cross-department communication.
- Ability to document and communicate problem/resolution and information/action plans.
- The ability to contribute to a team environment with a high degree of professionalism and skill.
- Demonstrated flexibility within a dynamic, fast-paced, cross-functional team
- Demonstrated ability to complete multiple tasks concurrently and deliver results in a challenging environment.
- Ability to work under stringent deadlines.
- Competent in the use of Word and Excel
For further information on this QA System Specialist position please contact Gavin Kennedy at The RFT Group on 01 2302400 / email@example.com
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