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Senior Quality Specialist (Quality Center of Excellence) Cork Ireland,  

MSD (company)

Posted on : 25 May 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.
  • 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.

Primary activities/responsibilities:
  •  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.

Job Segment:  Law, Pharmaceutical, Supply, Quality Assurance, Compliance, Legal, Science, Operations, Technology                       


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