Quality Specialist Job

Date: Mar 28, 2019

Location: Cork, IE

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Requisition ID: QUA008654

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


MSD Brinny

Are you ready to Invent, Impact, Inspire?

Join MSD and shape the future of healthcare in Ireland

INTRODUCTION 

At MSD Ireland, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.

THE COMPANY 

MSD Ireland is one of the country’s leading healthcare companies, having first established here over 50 years ago.
We currently employ over 1,700 employees, across four sites in Ballydine, Co Tipperary, Brinny, Co Cork, Carlow and Dublin and, in addition, operate substantial Human Health and Animal Health businesses. 
In total to date, we have invested $2.5 billion in our Irish operations and our annual turnover ranks us as one of Ireland’s top 20 companies. Currently, our Irish sites manufacture approximately half of MSD’s top twenty products, saving and enhancing lives in over sixty countries around the world.
With almost 70,000 employees operating in more than 140 countries, you will be joining one of the world’s largest pharmaceutical companies.

MSD BRINNY

MSD Brinny is a leading facility for the development, testing and manufacturing of new biologics and vaccines, exporting to over 90 countries across the world. With a team of approximately 500 people, MSD Brinny specialises in the late-stage development and commercial supply of biotech products, including some of the company's most successful and life-changing treatments for oncology, hepatitis C and rheumatoid arthritis. 
The Brinny site has been a vibrant part of the local Innishannon community for nearly 35 years and is now one of the region’s largest employers. MSD has invested €130m in the site since 2016 as a result of increased global demand for MSD medicines and vaccines which will see MSD Brinny further expand its production facilities and capacity to meet this demand. 

Our Manufacturing Division, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.



& SPECIFIC OBJECTIVES

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our Manufacturing Division  is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Specialist will provide quality and compliance guidance within the Quality Operations Team embedded in the Vaccines Integrated Process Team (IPT).  This team will manufacture and supply quality pharmaceutical products in meeting our Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.

The team working style is one of collaboration, coaching and facilitating the IPT to ensure success. The Quality Specialist is accountable for the Quality oversight of the Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment modelling the MSD Leadership behaviors in the IPT.
 
The Quality Specialist will have proven capability in engaging as an active member, across cross functional teams, to deliver process improvement. The Quality Specialist will model the MSD Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organisation.

The Quality Specialist will participate and comply with the MSD Quality Management System (QMS) requirements, including ownership, as relevant to you and IPT.


Primary activities/responsibilities:
  • Provides knowledge and experience in MSD Quality Management System (QMS). 
  • Uses knowledge to improve Quality Systems, identify problems and analyse solutions, provide continuous improvement and execute tasks.
  • Provides compliance contribution to project teams and may lead projects, as required.
  • Coaches and guides colleagues within the IPT.
  • Understands and applies regulatory and compliance requirements to their role while 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.
  • 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 IPT.
  • Ensure highest safety standards.

Qualifications

Required:
  • Degree or 3rd level qualification (Science discipline, Quality Assurance). 
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation 
  • 3 - 5 years’ experience in the Pharmaceutical/Biopharmaceutical industry or a similar operating environment which includes experience in a Quality function
  • Knowledge and experience in interpreting current QMS, regulatory requirements and providing independent support to the IPT
  • Demonstrated ability to work independently and fully realise improvement initiatives with a moderate level of guidance
  • Demonstrated ability to engage and succeed within teams.
  • Demonstrated ability to drive the completion of tasks within timelines.
  • Proven track record of providing independent Quality guidance to IPT.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Stakeholder management of multiple decision makers, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  • Proven decision-making capability within guidelines and policies.
  • Demonstrated efficient communication and coaching skills.
  • Demonstrated ability to identify problems and analyse solutions.


Desired:
  • Desirable evidence of Continuous Professional Development.


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.

So, if you are ready to: 

INVENT solutions to meet unmet healthcare needs 

IMPACT the future by joining MSD, one of the world’s leading healthcare companies 

INSPIRE your team to reach their full potential and push the boundaries of science and technology 

#featured
#brinny


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.


MSD is not accepting unsolicited assistance from search firms / recruitment agencies for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means. 


Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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