Senior Specialist, Quality Assurance Job

Date: Jun 17, 2019

Location: Carlow, IE

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Requisition ID: QUA008638

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 Ireland (Carlow)

 

 

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 CARLOW

 

MSD in Carlow is a world-class manufacturing facility, and the company’s first stand-alone vaccine and biologics facility outside the US. Carlow employs over 350 highly skilled employees and is an important element of MSD’s network of sites, playing a pivotal role in the manufacture of our immuno-oncology treatment.

 

MSD Carlow is a state-of-the-art, 200,000 sq ft vaccines and biologics facility focused on formulating and filling vaccine and biologic products that improve and transform the lives of people across the world.

 

MSD’s sustained investment in Ireland empowers Carlow to offer its team the opportunity to continuously grow, learn, invent and thrive. We are growing our highly-skilled team and building our presence in Carlow so that we can continue to lead scientific breakthroughs in the treatment of some of the world’s most harmful diseases.

 

MSD recently announced that it is to construct a second manufacturing facility at its existing site in Carlow with the creation of 150 new jobs. The new facility will focus on the production of vaccines and biologics. The site will also see the expansion of its warehouse.

 

 

& SPECIFIC OBJECTIVES 

 



  • The project Senior Quality Specialist role is critically important to ensure efficient and effective compliant design, construction, qualification, approval and operation of the new strategic MSD facility.  The Senior Quality Specialist will be responsible for supporting multiple Quality Assurance strategies, systems and processes for all phases of the project and will report to the MSDC Quality Lead for the project 


  • To maximize the development opportunity, the Senior Quality Specialist role may focus on areas such as Commissioning, Qualification and Compliance covering Utilities, Manufacturing requirements, Deviation and Change Control ownership.  In addition, the Senior Quality Specialist will be responsible for maintaining cGMPs for assigned areas within the capital project of designing, building, commissioning and qualifying a sterile Drug Product manufacturing facility, in conformance with MSD policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations


  • The candidate will work with a high performing cross functional team of talent sourced from across MSD and the biotechnology industry.  Together, the team will build the future of MSD biologics through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team


  • The candidate will provide quality support to the project and site, including training and guidance on the interpretation and implementation of MSD Guidelines / Policies and regulatory requirements

 

   

POSITION RESPONSIBILITIES

 



  • Track record in a similar role with at least 5 years’ experience


  • QA support including critical/ constructive review of GMP documentation associated with URS, FAT, SAT, IC, OC, IQ, OQ, PPQ and commercialization to meet schedule milestones.


  • Review and approval of Master records, executed records, investigations, change controls, SOPs, validation protocols, reports


  • Quality Representative for project workstreams


  • Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to the project and commercial operations.


  • Foster a culture of continuous improvement by deploying MSD Six Sigma tools and support implementation of Model Area within operations from the start.

 

REPORTING STRUCTURE:

 

MSDC Associate Director of Quality
Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

 

Technical



  • Sterile filling processes and equipment and support services experience


  • Project and start-up experience an advantage


  • Lean Six Sigma Methodology experience desired

 

Education



  • Degree qualification or equivalent (Science, Engineering, Technical)


  • Experience in Sterile Manufacturing


  • Evidence of continuous professional development is desirable

 

General



  • Demonstrate Leadership behaviours


  • Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes one’s department supports


  • Strong influencing skills


  • Demonstrable analytical and systematic problem-solving skills

 

People



  • Focus on Customers and Patients


  • Collaborate


  • Act with Candour and Courage


  • Make Rapid, Disciplined Decisions


  • Drive Results


  • Demonstrate Ethics and Integrity

 

 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

 

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.

 

Search Firm Representatives Please Read Carefully: 

MSD is not accepting unsolicited assistance from search firms 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: Qual Assurance & Ops Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 15 % of the Time
Number of Openings: 3
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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