- 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 Pharmaceutical or biotechnology industry
- Experience in GMP/GDP QMS
- Experience in 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 Associate position please contact Gavin Kennedy at The RFT Group on 01 2302400 / firstname.lastname@example.org. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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