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Senior Quality Specialist (Quality Center of Excellence) Cork Ireland,
Posted on : 25 May 2017
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- This position within the QA department will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the company priorities of: Compliance, Supply, Strategy and Profit Plan.
- The team working style is one of collaboration, coaching and facilitation to ensure the success of the site.
- The Senior Quality Specialist is 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 Senior Quality Specialist will have proven capability in development of Quality Systems as an active member, across cross functional teams, to deliver process improvement.
- The Senior Quality Specialist will model the company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.
- The Senior Quality Specialist will participate and comply with the company Quality Management System (QMS) requirements, including ownership.
- 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
- Supplier management oversight
- 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.
- Degree or 3rd level qualification (Science, Quality).
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation
- 3 - 5 years experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function
- 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 independently and fully realize improvement initiatives with a moderate level of guidance.
- Demonstrated ability to work and succeed within teams as well as leading small project teams.
- Demonstrated ability to drive the completion of tasks.
- Proven track record of providing independent Quality support to the site.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
- Proven decision making capability with full accountability and responsibility.
- Demonstrated coaching skills.
- Demonstrated ability to solve problems.
- Desirable evidence of Continuous Professional Development.
- Qualified Auditor.
- Our employees are the key to our company s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
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