Quality Assurance Documentation Controller

at  Viatris

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 I will be responsible for the day to day management of the site GMP documentation system. The role will also assist 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 Documentation Controller role will make an impact:

• Work with the Quality systems owner to coordinate, review, and manage the site control of GMP documents.
• Perform a detailed review of document changes prior to final approval.
• Manage the distribution of new documents and or retrieval of old documents (internally & externally).
• Coordinate the archiving of quality records.
• Assist in the preparation, revision and review of quality system records.
• Assist in the maintenance and delivery of quality related training applicable to your job role.
• Assist in the management of the incident report, CAPA, change control and Customer Complaints systems as required.
• Prepare weekly/monthly/quarterly/annual KPI/Management review data as required.

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. Experience within a pharmaceutical/medical device company desirable but not essential.However, a combination of experience and/or education will be taken into consideration.
• Knowledge and or experience of electronic document management systems is desirable but not essential.
• Must have excellent attention to detail, communication (oral & written) and interpersonal skills.
• 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.

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:

• 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.

Every day, we rise to the challenge to make a difference and here’s how the Quality Assurance Documentation Controller role will make an impact:

• Work with the Quality systems owner to coordinate, review, and manage the site control of GMP documents.
• Perform a detailed review of document changes prior to final approval.
• Manage the distribution of new documents and or retrieval of old documents (internally & externally).
• Coordinate the archiving of quality records.
• Assist in the preparation, revision and review of quality system records.
• Assist in the maintenance and delivery of quality related training applicable to your job role.
• Assist in the management of the incident report, CAPA, change control and Customer Complaints systems as required.
• Prepare weekly/monthly/quarterly/annual KPI/Management review data as required

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. Experience within a pharmaceutical/medical device company desirable but not essential.However, a combination of experience and/or education will be taken into consideration.
• Knowledge and or experience of electronic document management systems is desirable but not essential.
• Must have excellent attention to detail, communication (oral & written) and interpersonal skills.
• 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