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Principal Quality Specialist Cork Ireland,  

MSD (company)

Posted on : 04 June 2017

Project Description

  • 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.

Primary activities/responsibilities:
  • 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 MM
  • Quality Management System (QMS) requirements, including ownership.
  • Responsible for driving a culture of Continuous Improvement by deploying company 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 company Leadership behaviors 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.
  •  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.

  • 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.

Travel: Yes, 5 % of the Time

Job Segment:  Law, Change Management, Quality Assurance, Compliance, Six Sigma, Legal, Management, Technology                       


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