Quality Assurance Documentation Controller

About Viatris

Viatris is a global healthcare entity striving to integrate generics and branded pharmaceuticals to comprehensively meet worldwide healthcare demands. Serving roughly one billion patients yearly, the organization focuses on improving health outcomes throughout all life stages, covering acute and chronic conditions. Viatris is recognized on various prestigious award lists, highlighting its impactful contributions in the field. Its product catalog features a mix of iconic brand-name medicines, generics including complex variations, covering diverse therapeutic domains. Commitment to community health is underscored by initiatives in education, outreach, and improved treatment access.

The company fosters a collaborative work culture encouraging courage and resilience, aiming to empower employees to reach their full potential and make meaningful contributions globally.

Role Summary and Key Responsibilities

• Manage the daily operations of the site's Good Manufacturing Practice (GMP) documentation system and act as the administrator for the My University training quality system within the Quality team.
• Collaborate with the Quality systems owner to coordinate, review, and ensure control over GMP documents at the site.
• Support batch documentation issuance and reconciliation related to manufacturing records.
• Conduct thorough reviews of document changes prior to final approvals.
• Oversee the internal and external distribution and retrieval of new and obsolete documents.
• Coordinate archiving procedures for quality records.
• Assist in preparing, revising, and reviewing quality system documentation.
• Manage the My University curricula for the Quality Assurance team and coordinate training with Subject Matter Experts.
• Support management of material master data.
• Compile and report performance metrics for the Quality Assurance group.

Candidate Qualifications and Experience

• Possess at least a Bachelor’s degree or equivalent in a Science-related field.
• Experience in pharmaceutical or medical device sectors is preferred but not mandatory; a suitable combination of education and experience will be evaluated.
• Demonstrate meticulous attention to detail along with strong oral, written communication, and interpersonal abilities.
• Capable of multi-tasking effectively in a high-paced environment, with excellent organizational and time management skills.
• Proficient in working with diverse IT systems and software packages, with a strong command of Microsoft Office Suite including Word, Excel, and PowerPoint.
• Familiarity with electronic document management systems is advantageous but not essential.

Additional Information

Viatris is committed to fostering an inclusive and diverse workplace, encouraging all applicants who feel they align with the role, even if some qualifications are not met. Competitive salaries and benefits packages are provided.

Compensation and Benefits

• Opportunity for career advancement
• Initiatives supporting work-life balance
• Bonus programs
• Health insurance coverage
• Pension plan

Diversity and Sustainability

Diversity and equity are integral to Viatris’ mission, considered a driving force in transforming healthcare. The company is dedicated to responsible and sustainable operations influencing global communities positively.

Viatris is an equal opportunity employer committed to fairness in hiring and employment practices.