Quality Control Analyst

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 lifes 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.

Every day we rise to the challenge to make a difference and heres how the Quality Control Analyst role will make an impact:

Key responsibilities for this role include:

• Conduct routine and non-routine analyses of in-process materials finished goods and stability samples in a timely manner.
• Interpret test results and compare them with established specifications and control limits.
• Conduct chemical and physical laboratory tests to perform qualitative and quantitative analyses.
• Complete documentation required to support testing activities including data capture forms equipment logbooks and inventory records.
• Ensure compliance with Data Integrity principles and Good Documentation Practices (GDP) in all laboratory activities.
• Prepare technical reports graphs and charts to document experimental results.
• Participate in out-of-specification (OOS) out-of-trend (OOT) and laboratory failure investigations.
• Provide quality control data required for regulatory submissions as applicable.
• Investigate and report questionable or atypical test results to the supervisor.
• Perform data entry and trend analysis activities.
• Execute activities related to process validation cleaning validation and instrument qualification under supervision as applicable.
• Support the preparation and execution of SOPs calibration protocols validation protocols and qualification documents (IQ OQ and PQ) related to laboratory activities.
• Ensure implementation of Viatris Policies and requirements applicable to laboratory operations.
• Monitor reference standards inventory and expiry status.
• Monitor inventory and expiry status of laboratory stock items including reagents glassware filters and other laboratory consumables.
• Support the review and revision of Quality Control SOPs as assigned.
• Participate in continuous improvement initiatives including Lean and Six Sigma projects.
• Support QC compliance activities related to Viatris Policies internal audits EDA actions and data integrity requirements.

Experience and Knowledge

• Working knowledge of current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP) with particular emphasis on Quality Control operations.
• Knowledge of analytical laboratory techniques and laboratory instrumentation including pH meters UV-Visible spectrophotometers High-Performance Liquid Chromatography (HPLC) and reagent preparation.
• Familiarity with laboratory investigations data integrity requirements and Good Documentation Practices (GDP) is preferred.
• Experience with laboratory computerized systems and electronic data management is an advantage.
• Knowledge of pharmaceutical testing requirements specifications and regulatory expectations is preferred.

Minimum Qualifications for this Role

• Bachelors degree in Pharmacy Chemistry or Pharmaceutical Sciences.
• 12 years of experience in a pharmaceutical Quality Control laboratory.
• Good command of the English language both written and spoken.
• Strong technical writing documentation and communication skills.
• Proficiency in Microsoft Office applications (Word Excel and PowerPoint).
• Strong organizational analytical and problem-solving skills with the ability to work independently and effectively within a team environment.
• Ability to manage multiple priorities work under pressure and meet deadlines.

At Viatris we offercompetitivesalaries benefitsandan 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.