QA Executive Level II (6 Month Fixed Term Contract)

at  Viatris

Inverin, County Galway, Ireland -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate29 Jul, 2024Not Specified01 May, 20241 year(s) or abovePension,Management Skills,Deviation Management,Batch Release,Microsoft Office,Trackwise,Auditing,Health Insurance,Perspectives,Change Management,ExcelNoNo
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Description:

Mylan Teoranta
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
The Quality Assurance Executive II will be responsible for assisting with the co-ordination of all elements of the Quality System assigned to the Quality Assurance Department.

Every day, we rise to the challenge to make a difference and here’s how the Quality Assurance Executive II (6 Month Fixed Term Contract) role will make an impact:

  • Perform detailed batch record review of finished products prior to QP/QA release.
  • Assist with the maintenance of the incident report system, supplier non-conformance system and the CAPA system.
  • Perform detailed technical / quality review of all updated artwork. Approve final printed labelling (where applicable) and update master artwork files and packaging batch records.
  • Quality Oversight for site Packaging Operations.
  • Assist in the management of Customer Quality Complaints/Medical Device Vigilance systems.
  • Prepare monthly/quarterly/annual KPI/Management review data. Prepare annual product quality review reports.
  • Maintain the companies incoming inspection program.
  • Maintain and deliver quality related training to Viatris personnel.

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:

  • Minimum of a Bachelor’s degree (or equivalent) in a Science related discipline and 2-4 years’ relevant experience within a pharmaceutical company with a minimum of 1 years’ experience within a Quality Assurance role.
  • Experience of sterile manufacturing desirable but not essential.
  • Knowledge and or experience of all quality system aspects including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, batch release.
  • Experience of Trackwise or similar electronic document management systems is desirable but not essential.
  • Ability to handle multiple tasks in a fast-paced environment with strong organisational and time management skills.
  • Experience of working with various IT systems and software packages with strong working knowledge of Microsoft Office (word, Excel, powerpoint etc.)
  • Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

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:

  • Excellent career progression opportunities
  • Work-life balance initiatives
  • Bonus scheme
  • Health insurance
  • Pension

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
https://www.viatris.com/en/Careers/Diversity-and-Inclusion
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
https://www.viatris.com/en/about-us/corporate-responsibility
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.
Viatris is an Equal Opportunity Employer.

Responsibilities:

Every day, we rise to the challenge to make a difference and here’s how the Quality Assurance Executive II (6 Month Fixed Term Contract) role will make an impact:

  • Perform detailed batch record review of finished products prior to QP/QA release.
  • Assist with the maintenance of the incident report system, supplier non-conformance system and the CAPA system.
  • Perform detailed technical / quality review of all updated artwork. Approve final printed labelling (where applicable) and update master artwork files and packaging batch records.
  • Quality Oversight for site Packaging Operations.
  • Assist in the management of Customer Quality Complaints/Medical Device Vigilance systems.
  • Prepare monthly/quarterly/annual KPI/Management review data. Prepare annual product quality review reports.
  • Maintain the companies incoming inspection program.
  • Maintain and deliver quality related training to Viatris personnel

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

  • Minimum of a Bachelor’s degree (or equivalent) in a Science related discipline and 2-4 years’ relevant experience within a pharmaceutical company with a minimum of 1 years’ experience within a Quality Assurance role.
  • Experience of sterile manufacturing desirable but not essential.
  • Knowledge and or experience of all quality system aspects including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, batch release.
  • Experience of Trackwise or similar electronic document management systems is desirable but not essential.
  • Ability to handle multiple tasks in a fast-paced environment with strong organisational and time management skills.
  • Experience of working with various IT systems and software packages with strong working knowledge of Microsoft Office (word, Excel, powerpoint etc.)
  • Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems


REQUIREMENT SUMMARY

Min:1.0Max:4.0 year(s)

Pharmaceuticals

Production / Maintenance / Quality

Clinical Pharmacy

Graduate

A quality assurance role

Proficient

1

Inverin, County Galway, Ireland