Principal Quality Specialist - Ireland
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- 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.
- The Principal Quality Specialist will provide Quality oversight, support and expertise to GMP related activities and Quality Systems across the site and in meeting the Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.
- This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment.
- The Principal Quality Specialist will have proven capability in development of Quality Systems across cross functional teams to deliver process improvement.
- The team working style is one of collaboration, coaching and facilitation to ensure the success of the site.
- The Principal Quality Specialist is accountable for the Quality Systems within the site or where the role resides in the IPT will provide support to Operational Quality across site.
- Provides to the site and network, expertise in Quality Systems and/or Operational Quality, including the following i.e. Deviation/NOE/LIR coaching; GCM coaching; environment monitoring programs; sterile assurance; customer compliant investigations; etc.
- Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
- Coordinates the work of others within the team and in the site
- Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality
- Leads project teams.
- Coaches and guides colleagues within the site and also in the network.
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes
- Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
- Makes decisions within guidelines and policies which impact Product Quality, Projects and Quality Systems.
- Liaises with Corporate Quality to ensure alignment on actions related to Quality Systems and/or Operational Quality at the site.
- Coordination and/or participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
- Ensure supply of high quality product through implementation and oversight of the Quality Management System for the site.
- Works with other sites to aid them and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.
- Champions Permanent Inspection Readiness (PIR) and Quality and Compliance Excellence (QCE) programs.
- Ensure the highest Quality, Compliance and Safety standards.
- The Principal Quality Specialist will participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership.
- At least 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes a minimum of 2 years’ experience in a Quality function.
- Experience as QMS Sub System Owner as required for the Principal Quality Specialist role
- SME in at least 4 QMSs as required for the Principal Quality Specialist role
- Degree (in Science).
- Green belt or suitable alternative.
- Company Certified 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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