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 QC Chemist role will make an impact.

Role Purpose:

• Perform analytical and basic microbiological testing accurately and efficiently and in accordance to Standard Operating Procedures (SOPs).
• Perform equipment verification and calibration in accordance to procedures.
• Document all results in accordance to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements.
• Ensure all quality records are attached and/or file as predetermined.
• Write and review Standard Operating Procedures (SOPs) and On the Job Training (OJTs) for the laboratory.
• Perform maintenance and troubleshooting of laboratory equipment where required.
• Perform equipment qualification and analytical method validation where required.
• Perform laboratory equipment verification and calibration in accordance to procedures where required.
• Perform basic microbiological testing such as endotoxin level in water and products.
• Ensure all documentations and quality records are conducted in accordance to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements and that they are filed in accordance to existing policies.
• Participate actively and contribute to site project teams.
• Train fellow colleagues on written procedures and SOPs pertaining to equipment operation, analytical and microbiological test methods and general laboratory operation.
• Perform review and approval of test results via LIMS System.
• Advise on the significance of test results and follow up with appropriate course of actions.
• Actively participate in Safety initiatives, typically a role model for other analyst. Ability to perform investigation related to EHS.
• Participate in 5S team initiatives and practice good housekeeping.
• Lead and conduct laboratory investigations/incidents such as out of specification investigation and equipment troubleshooting investigations, identify root causes and implement appropriate corrective action and preventive measures.
• Participate in Analytical Method Transfer Exercise and independently resolve issues associated with test methods.
• Develop and validate test methods as required.
• Lead and manage laboratory equipment validation project independently.
• Review test reports and ensure that all laboratory documents are in a constant state of regulatory compliance and inspection readiness.
• Develop test methods or instrument Standard Operating Procedures (SOPs), write and update Quality Procedures.
• Plan and deliver technical training to colleagues. Developed and review training materials as required e.g. Basic lab techniques.
• Close coordination with cross function colleagues / Vendors to achieve desire outcome ( e.g. Lab equipment installation/ Validation/ Service contract / External contract lab testing fulfillment).
• Commitment to work and positive influencer/role model/motivate others for overall operational excellence.

Job Related Requirements

• Demonstrated leadership and customer service skills.
• Effective problem-solving skills.
• Strong verbal, written communication and presentation skills.
• Demonstrated ability to perform in a team.
• Comprehensive knowledge of cGMPs and appropriate regulations.
• Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment.
• Experience in Empower software/ SAP will be an added advantage

Accountability:

• Analytical testing
• Laboratory Non-conformance and Investigation management.
• Laboratory safety and housekeeping
• Procedures Development & Review
• Training
• Change Control Implementation

Key Performance Indicators (KPIs):

• Safety Performance.
• New Procedures/SOPs implementation.
• Lead time for QC testing.
• Project Milestones and Implementation.
• Compliance to GMP/GLP requirements.
• Timely completion of training.
• Timely laboratory investigation

Qualification

• Degree or Diploma in Science (preferably Chemistry) or Chemical Process Technology.

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.
• 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.
• Strong written and verbal communication skills.

Additional qualifications include :

• Laboratory work experience with analytical chromatographic technique.
• Knowledge of lean manufacturing, six sigma methodologies, and statistics.
• Experience leading continuous improvement projects.