Quality Control Chemist

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.

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.

Every day, we rise to the challenge to make a difference and here's how the Quality Control Chemist role will make an impact.

Role Purpose:

Reporting to the AS&T Manager / Supervisor, the primary role of the QC Chemist (AS&T) is to perform analytical method transfers from donating site, perform testing, review test results and provide technical support to the laboratory. In addition to method transfers, the incumbent is to support cleaning method development and its validation. The incumbent will also need to assess the compendial monograph updates for the TUAS site products and provide technical & regulatory support for the post transfer products.

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

1> Responsibility

• Perform analytical method transfer, method validation, method verification and method equivalency study in accordance to Standard Operating Procedures (SOPs), adhering to ALCOA principles and Data Integrity requirements
• Perform analytical testing accurately and efficiently following Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements
• Participate in 5S team initiatives and practice good housekeeping, ensuring all safety procedures are followed
• Able to assess the impact on products based on compendial monograph changes/updates/introduction
• Able to support regulatory submissions and queries for post transfer activity
• Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory
• Conduct Laboratory investigations and propose CAPA for the identified root cause
• Train colleagues in hands on training of instruments and methods written
• Perform review and approval of test results
• Able to write position paper, protocols, reports and test procedures
• Ability to handle Trackwise actions and raise and complete change controls for changes with GMP impact
• Involve in regular meeting with donating site and facilitate the smooth transfer of the methods
• Conduct training for fellow QC colleagues on new methods in the laboratory
• Contribute to the continuous improvement activities in QC laboratory or cross functional teams as nominated
• Play an active and impactful role in Tier processes by updating performance against metrics, highlighting issues, with appropriate escalation. Support development and implementation of solution
• Perform cleaning method development and validation
• Ensure following the site GDP practice on documentation and preparation of document
• Method verification in accordance to site or pharmacopeia standards and according to schedule
• Ensure training records are updated and promptly, are correctly filed to reflect current testing capabilities

2> Accountability

• Analytical testing, method transfers and review of test results to meet lead time in a right first-time manner
• Perform testing according to Standard Work Plan (SWP) as assigned
• Ensure training records are updated and promptly, are correctly filed to reflect current testing capabilities
• Method verification in accordance to site or pharmacopeia standards and according to schedule
• Support to QC for method trouble shooting
• Evaluate method robustness challenges and modify the method to improve method robustness if required
• Involve in regular meeting with donating site and facilitate the smooth transfer of the methods
• Compliance to GMP/GLP and Viatris Quality Standards requirements
• Understand and comply with Data Integrity and Good Documentation Practices (GDP) requirements
• Laboratory safety and housekeeping; and participate in laboratory housekeeping and 5S program responsibilities
• Wear Personal Protective Equipment (PPE) as required and observe safety instructions stated in Job Safety Analysis (JSAs), Standard Test Methods (STPs) and Material Application Document (MADs) and Laboratory Document (LAB).
• Perform test method validation & cleaning method validation of test methods in accordance to STP and USP/JP/EP requirements
• Complete validation documents reports as required
• Update SOPs to align with Viatris Quality Standards and regulatory requirement (USP, ICH guidelines etc)

3> Job Skill Requirement

• Demonstrated technical skills in method transfer, validation, verification and testing.
• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
• Knowledge of Good Manufacturing Practices and its application standards, processes and policies
• Excellent organizational skills and strong ability to multi-task across projects and activities
• Strong written and verbal communication skills
• Laboratory work experience with analytical HPLC, GC, FTIR, UV, KF and other lab equipment
• Experience leading continuous improvement projects
• Knowledge of lean manufacturing, six sigma methodologies, and statistics
• Experience in Method Transfer, Method Validation and Method Verification activity

Qualification

• Degree or Diploma in Science (preferably Chemistry)

Skills and Experience

• For a Diploma: A minimum of 5 years QC experience in the pharmaceutical or related industry
• For a Degree: A minimum of 3 years QC experience in the pharmaceutical industry