Quality Assurance Documentation Controller

Viatris; Connacht; On-site; EUR 42,000 - 56,000; Full time

Benefits offered by this job

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris in Ireland is seeking a Quality Assurance Documentation Controller to manage the site GMP documentation system and act as administrator of the My University training quality system for the QA team. You will coordinate, review, and manage control of GMP documents, support batch documentation issuance and reconciliation, and ensure timely distribution of new and old documents.

This role offers a collaborative environment with development opportunities and benefits such as health insurance

Qualifications

• Bachelor's degree in a science-related discipline.
• Experience in pharmaceutical/medical device industry desirable.
• Excellent attention to detail, communication and interpersonal skills.
• Ability to handle multiple tasks in a fast paced environment with good time management.
• Experience with IT systems and Microsoft Office; knowledge of electronic document management systems is desirable

Responsibilities

• Coordinate, review and manage site GMP document control.
• Support batch documentation issuance and reconciliation for manufacturing records.
• Perform detailed review of document changes prior to final approval.
• Manage distribution of new and retrieval of old documents.
• Coordinate archiving of quality records.
• Assist in preparation, revision and review of quality system records.
• Manage My University curricula for the QA team and coordinate training with SMEs.
• Support management of material master data.
• Collate and report QA performance metrics.

Skills

Communication

Attention to detail

Time management

Multitasking

Interpersonal skills

MS Office

Education

Bachelor's degree in science

Tools

Electronic document management systems

Job description

Mylan Teoranta

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

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 Documentation Controller will be responsible for the day to day management of the site GMP documentation system, acting as administrator of My University training quality system for the Quality team. 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.
• Support batch documentation issuance and reconciliation for the manufacturing records.
• 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.
• Manage the My University curricula for the QA team and coordinate Training with SME(Subject Matter Expert) for the Quality team
• Support the management of material master data
• Collate and report the performance metrics within the QA group.

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.
• 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.)
• Experience of electronic document management systems is desirable but not essential

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.