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 Analyst (Stability and Methodology) role will make an impact:
Position summary:Conduct routine and non-routine analysis and relevant documentation and reporting.Performance of lab-related tasks.Job Specific technical/Functional/Professional Competencies:
Conduct stability & method validation testing and the corresponding documentation to support the timely disposition of product.Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.Write technical reports or prepare graphs or charts to document experimental results.Participate in out-of-specification and failure investigations and recommend corrective actions.Supply quality control data necessary for regulatory submissions.Investigate or report questionable test results.Manage stability chambers.Execute all activities related to process, cleaning, and instrument validation.Prepare and execute the SOPs, calibration, and validation documents (IQ, OQ & PQ) related to chemical laboratory tasks.Using, monitoring, and controlling of laboratory chemical reagents inventory and expiryPerform Data loggers monitoring, downloading, and reviewing.Work on improving his/her process by implementing lean and 6σ projects.Ensure that all results generated follow data integrity requirements and following ALCOA principles all over operations.Comply with all Viatris Quality Standards and procedures.Knowledgeable with basic Laboratory instruments such as pH, Spectrophotometry, HPLC and reagent preparation.Raise “NTM” Notification to Management whenever condition in Viatris policies applies.Support Supply department by sending stability samples on time, evaluation of stability results and taking any immediate actions required in addition to archive of these results for toll manufacturing products.Create/review of stability schedule, protocols, reports, and trends.Follow up stability equipment calibration & maintenance and ensure appropriate documentation and archiving.Maintain laboratory supplies inventory required for Stability analysis.Handle the global changes affecting stability and methodology.Support QA with all CCRs and QARs related to Stability & Methodology.Perform all method validation activities required.Create/review of method validation protocols and reports.Experience and Knowledge
Good command of English in both written and spoken.Excellent in Microsoft office (word, excel & PowerPoint)Knowledgeable with interpersonal, good communication and presentation skills.cGMP & cGLP knowledge is preferred with particular emphasis on Quality Control.Knowledgeable with Laboratory instruments such as pH, Spectrophotometry, HPLC and reagent preparation.Essential Personal Qualifications
Bachelor’s degree in pharmacy or science.1-5 years’ experience in a related area.Demonstrated ability to work independently.Excellent documentation and technical writing skills.Able to work in a team, interact with various priorities and meet deadlines.Active, organized and planner with high attention to details.High observation skills.Self-motivated and able to consistently meet timelines.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.
Viatris is an Equal Opportunity Employer.