Senior Quality Assurance Specialist

Viatris; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Viatris Singapore invites applications for a Senior QA Specialist (Compliance). You will drive GMP-compliant quality culture at the site, work with cross-functional SMEs, and support regulatory inspections to ensure readiness.

Your responsibilities include reviewing GMP documents, managing supplier quality, and maintaining audit-ready records in a fast-paced global pharmaceutical environment. You will collaborate with site training, GCMC, and BoH teams to address inquiries, support regulatory

Qualifications

• Degree or Diploma in Science or Pharmaceutical/ Chemical Engineering.
• Experience in GMP and quality systems is preferred.
• Ability to work in a cross-functional, global environment.

Responsibilities

• Review and approve GMP documentation and ensure site compliance with policy and SOPs.
• Maintain site inspection readiness and support regulatory inspections.
• Qualify and manage suppliers, review quality issues, and track remediation.
• Collaborate with training and regulatory teams to address BoH queries.
• Conduct internal audits and drive CAPAs, deviations, and change controls.
• Prepare quality metrics reporting and management reviews.

Skills

MS Office

Excel

Cross-functional collaboration

Analytical thinking

Problem solving

Documentation

Regulatory compliance

Attention to detail

Education

Degree or Diploma in Science or Pharmaceutical/ Chemical Engineering

Tools

Electronic Quality Management System (eQMS)

Job description

Viatris Inc. (NASDAQ: VTRS) 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.

With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris.

We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India.

Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X.

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.

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

Viatris is an Equal Opportunity Employer.

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.

• 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.

Every day, we rise to the challenge to make a difference and here’s how the Senior Quality Assurance Specialist role will make an impact.

Role Purpose

Reporting to the Quality Assurance Manager (Compliance), the role of the QA Specialist / Senior QA Specialist (Compliance) is to drive quality culture and promote GMP compliance to site, collaborate with cross functional subject matter expert (SME) to improve quality system, understand regulatory expectations and support site inspection readiness, provide quality oversight to supplier management to ensure purchased material meet specification, collaborate with GCMC to support regulatory filing activities and addressing board of health queries.

Key responsibilities for this role include, but not limited to:

• Review and approve GMP documentation and ensure site compliance with Corporate Policy and Standard Operating Procedure (SOPs).
• Ensure accurate reporting of site quality metrics and facilitate management review to proactively identify trends and atypical observations.
• Conduct internal audits to ensure site compliance to Viatris Quality Policies and applicable regulatory requirement.
• Maintain site inspection readiness. Support site inspections readiness activities and logistic during regulatory inspection, customer audit and corporate audit. Support written response to Board of Health (BoH) within expected due date when required.
• Qualify and manage suppliers during the lifecycle according to SOPs and maintain accurate records of supplier status. Review quality related issues and investigation from suppliers and ensure remediation action plan is adequate to mitigate compliance risk.
• Establish quality agreement with supplier and maintain the quality agreement throughout its lifecycle.
• Conduct supplier audit as required to ensure supplier conforms to Viatris global policies and applicable regulatory requirement.
• Collaborate with site Training department to conduct annual cGMP training.
• Collaborate with GCMC to support regulatory filing activities. Coordinate with site SME to address queries from BoH accurately and timely. Track regulatory commitment to ensure completion within committed timeline.

Qualification

• Degree or Diploma in Science or Pharmaceutical/ Chemical Engineering

Skills and Experience

Some of the key competencies required:

• Proficient in Microsoft Office applications, including Excel, Word, PowerPoint, Outlook, and Teams.
• Preferred experience with Electronic Quality Management Systems for management of deviations, CAPAs, change controls, document management, and training records.
• Ability to analyze and trend quality data using spreadsheets and reporting tools.
• Effective collaboration and ability to work in a cross-functional global environment.
• Strong analytical, problem-solving, and risk assessment capabilities.
• Strong attention to detail and organizational skills.
• Ability to influence and negotiate with internal and external stakeholders.
• Demonstrated integrity, sound judgment, and commitment to quality and compliance.
• Ability to manage multiple priorities and deliver results in a dynamic environment.
• Adaptability and continuous learning mindset.
• Senior QA Specialist: Degree holder with a minimum of 3 years’ experience in Quality Assurance role within the pharmaceutical industry or Diploma holder with minimum of 5 years experience in Quality Assurance role within pharmaceutical industry.
• QA Specialist: Degree Holder with a minimum of 1 year experience in pharmaceutical industry or related industry or Diploma holder with a minimum of 3 years’ experience in.