Principal Quality Specialist Cork
Our client, a pharmaceutical device company in Cork are currently looking to recruit a Principal Quality Specialist for their site.
- 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 (MMD) 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 MMD
- Quality Management System (QMS) requirements, including ownership.
- Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools within the IPT
- The Principal Quality Specialist will have proven capability in development of Quality Systems across cross functional teams to deliver process improvement. Model the Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.
- 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.
- Certified Auditor.
- Demonstrated change management skills (CEM) with continuous improvement.
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc).
- Quality Assurance SME knowledge from both operational and educational experience, is required
- Demonstrated expertise in Quality Management Systems.
- Demonstrated use of Leadership Behaviours
- 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 minimal guidance.
- Demonstrated ability to co-ordinate the work of others, as well as leading project teams.
- Demonstrated ability to drive the completion of tasks.
- Proven track record of providing independent Quality expertise to the site.
- Demonstrated delivery of SME knowledge above site.
- Demonstrated successes in a team environment, such as project teams, Six Sigma team, Tier 4s etc.
- 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 clarify, communicate and solve complex problems.
For further information on this Quality Engineer II role in Cork please contact Bimi Felix on 091730022 / firstname.lastname@example.org
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