Quality Assurance Role
This position involves overseeing the preparation, review and approval of GMP documentation, ensuring compliance with regulatory requirements. You will participate in training initiatives, preparing and delivering GMP training modules, as well as other required training for plant personnel.
Your responsibilities will include managing the process deviation system, timely preparation of deviation investigation reports, and effective management and control of change controls. Additionally, you will assist in preparation for and participation in regulatory and customer audits, generating and reporting quality metrics monthly, and participating in GMP and Continuous Improvement projects within QA and on site.
As a key member of the team, you will adhere to current Good Manufacturing Practice, maintain your place of work in a clean and tidy state at all times, and participate in all training and assessment activities. You will also ensure that all work is carried out in a safe manner, adhering to company safety policies, procedures and regulations issued by Viatris Damastown.
About Your Skills & Experience
We are looking for a candidate with an effective combination of the following qualifications, skills and experiences:
Bachelor's degree in Science (equivalent/related industry experience) and relevant experience in a pharmaceutical or other life science organisation. The ideal candidate will have previous experience managing deviations, change controls, CAPAs, compiling annual product quality reviews, change management,
A strong problem-solving skill, attention to detail, good understanding of EU GMP and proficiency in speaking, comprehending, reading and writing English. As a team player willing to support organisational needs/activities, ability to perform in a fast-paced environment, ability to work independently and experience in TrackWise, MES, SAP, LIMS.
Why Choose Us?
We offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to make an impact on the lives of others. You will also have access to excellent career progression opportunities and work-life balance initiatives. Our commitment to diversity, equity, and inclusion fosters a culture that values collaboration, innovation, and growth. We strive to advance responsible and sustainable operations, leveraging our collective expertise to empower people to live healthier at every stage of life.