A Quality Specialist is required for a biopharmaceutical in West Cork. The successful candidate will be accountable for the Quality Systems within the site. This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment. The Quality Specialist will have proven capability in development of Quality Systems.
- Provides to the site knowledge and experience in Quality Systems.
- Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement, and execute tasks.
- Provides compliance contribution to project teams and leads small projects.
- Coaches and guides colleagues within the site.
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
- Responds to non-standard requests from customer needs.
- Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
- Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
- Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
- Participation in and leading internal inspections
- Participate in GMP Walkthroughs.
- Deviation Management & Change Control approval.
- Ensures supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
- Champion the highest Quality and Compliance standards for the site.
- Ensure highest safety standards.
Qualifications & Experience:
- Degree or 3rd level qualification (Science, Quality).
- 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.
- Quality Assurance SME knowledge, from both operational and educational experience, is required.
- Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site.
- Demonstrated ability to work and succeed within teams as well as leading small project teams.
- Proven track record of providing independent Quality support to the site.
Advanced PC skills such as Excel, Word, PowerPoint.
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