Quality Specialist

Summary:
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.

Responsibilities:

• 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.