- Management and Review of market Complaints for in-network and 3rd party complaints/issues notified to the company.
- To administer and develop the Change Control System and Deviation System in accordance with the relevant SOP's and to coordinate the follow up and closure of all open items in relation to both.
- Administration/co-ordination of risk assessments.
- To maintain and develop the SOP system in relation to the update, logging, and distribution of SOP's.
- To maintain & coordinate the MAH Approved Supplier & Product listing.
- To ensure Technical Agreements are in place with affiliate and third-party contractors.
- To collate information and assist in the preparation of reports in relation to Annual Product Quality reviews for all products where we are MAH.
- To ensure that the systems with a GMP or GDP impact are maintained as per written procedures and are in a state of audit readiness at all times.
- To support the internal audit procedure
- To adhere to all company and legislative health, safety, and environmental requirements.
- Any other duties as assigned by the Quality Systems Supervisor or Manager.
- To perform Bona Fide checks as per GDP guidelines
- To manage the product returns procedure
- Any other GMP/GDP activity assigned by the Quality Systems Manager - 3rd level qualification in science related discipline.
- Experience of Quality Systems in a Pharmaceutical environment would be of benefit.
- Relevant experience in GMP/GDP environment.
- Strong organisational skills / ability to prioritize work.
- Proven track record as a team player.
- High level of proficiency in Microsoft Word/Excel.
- Excellent career progression opportunities
- Work-life balance initiatives
- Bonus scheme
- Health insurance
- Pension
Quality Systems Specialist - Dublin, Ireland - Viatris
Description
McDermott Laboratories Limited At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
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Every day, we rise to the challenge to make a difference and here's how the Quality Systems Specialist role will make an impact:
About Your Skills & Experience
For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit
At Viatris, we offercompetitivesalaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.