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Principal Quality Specialist, Biologics - Ireland
Posted on : 22 April 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.
- 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.
- 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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