Quality Control Analyst
2 weeks ago
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 Finished Products Analyst) role will make an impact:
- Position summary:
- Conduct routine and nonroutine analyses and relevant documentation and reporting.
- Performance of labrelated tasks.
Key Responsibilities for this role include:
- Conduct routine and non-routine analyses of in-process materials, finished goods, or stability samples in a timely manner.
- Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
- Conduct chemical or physical laboratory tests in making qualitative or quantitative analyses
- 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.
- Calibrate, validate, or maintain laboratory equipment.
- Participate in outofspecification and failure investigations and recommend corrective actions.
- Supply quality control data necessary for regulatory submissions.
- Investigate or report questionable test results.
- Addition and withdrawal of stability samples from stability chambers
- Performance of data entry and trend analysis
- Reviewing, filing, reporting and trending of stability data
- Perform the Analytical Method Transfer Exercise (AMTE) for the new test procedures required for manufacturing of new product in our site.
- Perform Validation required for the new developed test procedures.
- Execute all activities related to process, cleaning, and instrument validation.
- Preparing and executing the SOPs, calibration, and validation documents (IQ, OQ & PQ) related to chemical laboratory tasks.
- Implementing the Viatris Policies' requirements regarding the chemical laboratory
- Using, monitoring, and controlling Reference standards inventory and expiry
- Using, monitoring, and controlling of expiry and inventory of laboratory stock items including reagents, glassware, filters, etc.
- Perform Data loggers monitoring, downloading, and reviewing
- Writing and revision of Quality Control SOP's
- Working on improving his process by implementing lean and 6σ projects.
- Responsibility for implementation of Data integrity program in the relevant work area and insure following up ALCOA principles all over operations.
- Active implementation of Notification to Management procedures.
- Responsibility for compliance with Viatris Quality Standards.
- Knowledgeable with basic Laboratory instruments such as pH, Spectrophotometry, HPLC and reagent preparation.
- Responsible for ensuring that all results generated follow data integrity requirements.
- Responsible for raising "NTM" Notification to Management whenever condition in Viatris policies applies.
The Minimum Qualifications for this role include:
- Bachelor's degree in Pharmacy or Science.
- 12 years' experience in a related area.
- Good command of English in both written and spoken.
- Excellent in Microsoft office (word, excel & PowerPoint)
- Knowledgeable with interpersonal, good communication and presentation skills.
- Knowledgeable with Laboratory instruments such as pH, Spectrophotometry, HPLC and reagent preparation.
- Demonstrated ability to work independently.
- Must be able to work in a stressful, ondemand environment and be able to communicate under stress in a nonconfrontational, effective manner.
- 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.
- Hard worker & selfmotivated.
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.
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