Quality Control Analyst (Stability & Methodology)

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 (QC Stability and Methodology Analyst) 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.
• Perform 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 Notification of critical quality events 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 Deviations 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

• Bachelors degree in pharmacy or science.
• 1-3 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 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.