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Senior Development Quality Specialist

Merck
Tipperary
38 days ago: Merck

Job Description

Requisition ID: CLI007891
MSD Ballydine
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 BALLYDINE
MSD Ballydine develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Tipperary for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan.
Our highly-skilled local workforce of 500 employees is now leading the way in the development of new medicines, including MSD’s treatment for hepatitis C, which is being manufactured in Tipperary for patients around the world.
MSD Ballydine’s existing portfolio and future pipeline offers team members the opportunity to operate at the cutting-edge of science and technology, and develop new treatments that positively impact patients across the globe.
& SPECIFIC OBJECTIVES
We are creating a new Quality team in MSD Ballydine Ireland to support the expanding MSD Clinical Trials programs in Europe. As part of this expansion, we are looking to recruit two experienced Development Quality Specialist to undertake auditing and reviewing of materials to support the release of clinical trials supplies.
POSITION RESPONSIBILITIES
The Snr Development Quality Specialist will be involved in the review of batches intended for use in clinical trials, to ensure compliance with EU GMP, the Product Specification File and the Clinical Trial Application. This will encompass batches manufactured across the MSD Supply Chain and subsequently imported into the EU. Following the review, the batches will then be QP certified prior to use in the EU.
Additionally, the successful candidate will be involved with Health Authority Inspections to maintain the site licences, as well as ongoing compliance activities related to clinical trials, for example technical and quality agreements with collaborators, stock recovery activities, Quality Systems support including change management, investigations and clinical complaints etc.
REPORTING STRUCTURE
This role will report to the Director of Development Quality.
Qualifications

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
General
Knowledge and experience working in a cGMP environment is preferred
Technical
Knowledge of the requirements for Clinical Trials in the EU is preferred
People
A focus on teamwork as well as the ability to work independently on required tasks is essential.
Education
A degree or equivalent qualification in a life sciences or engineering discipline.




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.



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




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: Clinical, Non Clinical Quality Assurance
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD
Requisition ID: CLI007891 MSD Ballydine 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,...