Quality Assurance Specialist (2-year FTC)Apply locations Dublin time type Full time posted on Posted 2 Days Ago time left to apply End Date: January 24, 2025 (11 days left to apply) job requisition id 202501-100480
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We believe that inclusion is key to understanding people's varied healthcare needs.
Together, we embrace individuality and share a passion for exceptional care.
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The PositionRoche Products (Ireland) Limited (RPIL) is the sales & marketing arm in Ireland of the pharmaceutical division of Roche.
We market and sell prescription medicines across a range of therapeutic areas including oncology, neurology, ophthalmology, rheumatology and spinal muscular atrophy.
We are an agile organisation that brings together great people who are passionate about innovation and who thrive in dynamic, cross-functional, and purposeful teams.
These teams work together to deliver outstanding value to our business, patients, and customers.
This vacancy, which is for a fixed term contract of two years, arises as our Quality Officer is on secondment to a global project for that period.
The role is working within the Finance & Business Operations team which includes Finance, Supply Chain, Quality, Procurement, Business Support and Administration.
You will ensure compliance with the requirements of RPIL Good X Practices (GxP) and associated Pharmaceutical Quality System (PQS) activities.
You will be making sure that RPIL operates in compliance with its GxP requirements so that the quality, safety and efficacy of our products is ensured during our delivery of better outcomes for more patients faster.
You require a broad set of skills in communication, interpersonal relationships, managing business relationships, managing a diverse workload and an ability to manage your time effectively.
Comfortable working both as a part of a team as well as on your own initiative, you will have proven organisational capability & high levels of personal effectiveness.
You will possess a working knowledge of GxP and applicable Irish statutory requirements and EU Directives.
A knowledge of Good Manufacturing Practices is desirable.
You will possess strong intellectual, analytical and thinking skills and will be experienced working across the MS Windows and Google platforms.
The role will be based in our office in Citywest in Dublin. What you could be working on: Execute Quality related activities, as specified in Standard Operating Procedures (SOPs) or required to meet regulatory requirements;
Assess compliance with the PQS by conducting periodic checks of GxP processes governed by SOPs;
Ensure the affiliate is prepared for internal/external GxP audits and inspections;
Identify and implement continuous improvement opportunities;
Provide operational support to other Roche affiliates in the network for key quality activities;
Provide insight and guidance to the business in relation to GDP and quality matters;
Act as MAP (Market Research and Patient Support Programmes) Lead (deputy), as/when agreed;
Act as Deputy Responsible Person (DRP) when the Responsible Person (RP) is absent or when RP tasks are delegated, as described in GDP Guideline 2013/C 343/01.
Essential Qualifications: The ideal candidate will ideally have a BSc in life sciences/health sciences or equivalent and previous experience in a regulated environment.
Application Process: Phase I:
Purpose - our focus on this first stage is to understand why you have applied for this role and what you will bring to the role to ensure team and personal success.
Cover letter & CV
As part of your cover letter, Roche is keen to understand your motivation in applying for this position.
You should, therefore, provide responses to the following:
Why Roche: What do you know about Roche and why do you want to work here?
Why you: If you had to choose a single example or achievement in your life, that you feel would make you suitable for this role, what would it be and why?
Your cover letter should not exceed one page.
Phase II:
In person interview: January/February 2024
Start Date: ASAP
Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare.
Working together, we've become one of the world's leading research-focused healthcare groups.
Our success is built on innovation, curiosity and diversity.
Roche Products (Ireland) Limited was established as a full affiliate of F. Hoffman-La Roche.
The company is based in Citywest in Dublin 24, and deals with the commercial aspects of our Irish business, including sales and marketing, finance, regulatory and medical affairs for the Pharmaceutical Division.
Roche is an Equal Opportunity Employer.
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