Overview
QA Officer (12 months contract) at Viatris. Join to apply for the QA Officer role at Viatris.
Viatris empowers people worldwide to live healthier at every stage of life. We do so via Access, Leadership and Partnership, focusing on high quality medicines, sustainable operations and collaborative solutions. Viatris is an Equal Opportunity Employer.
The Role & What You Will Be Doing
GMP documentation preparation, review, approval and management of the D2 system used onsite.
Participation in training initiatives including preparation and delivery of GMP training modules and other training modules as required for plant personnel.
Preparation of Annual Product Quality Review reports.
Management and control of the deviation system, including timely preparation of deviation investigation reports.
Management and control of the change control system, ensuring all change controls are approved in a timely manner.
CAPA management.
Assisting in preparation for and participation in regulatory and customer audits.
Generation and reporting of Quality metrics monthly.
Participation in GMP and Continuous Improvement projects within QA and on site.
Other duties as required and as directed by the Senior Quality Compliance Manager.
All activities performed in accordance with current Good Manufacturing Practice (GMP).
Adhere to relevant EC GMP directives and guidance as interpreted in the EC guide to GMP.
Maintain a clean and tidy place of work; participate in all training and SOP training and assessment related to the job.
Attend all training courses (internal and external) as required for training related to the job.
Ensure all training and assessment is recorded on the Individual Training Record, in conjunction with the Senior Quality Compliance Manager or designee.
Adhere to safety policies, procedures and regulations issued by Viatris; work safely and report any breaches or hazards promptly.
Complete Accident report/Near Miss Forms in a timely manner after an event.
About Your Skills & Experience
For this role, we’re looking for a candidate with the following qualifications, skills and experiences:
Bachelor’s degree in Science (equivalent/related industry experience).
Relevant experience in a pharmaceutical or life science organisation.
Experience managing deviations, change controls, CAPAs, compiling annual product quality reviews, and change management.
Strong problem solving and attention to detail.
Good understanding of EU GMP.
Proficiency in English (speaking, reading, writing).
Team player willing to support organizational needs and activities.
Ability to perform in a fast-paced environment and to work independently.
Experience with TrackWise, MES, SAP, LIMS and proficiency in MS Office applications (Word, Excel, PowerPoint).
Why Viatris
Viatris offers competitive salaries, benefits and an inclusive environment where you can make an impact on the lives of others and have opportunities for career progression and work-life balance.
Diversity & Inclusion
Viatris values diversity and inclusion as essential to our mission. To learn more, visit our Diversity and Inclusion page.
Sustainability
We are committed to responsible and sustainable operations and corporate responsibility initiatives. To learn more, visit our Sustainability page.
Equal Opportunity
Viatris is an Equal Opportunity Employer.
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