Quality Control Analyst ( Finish Goods) At Viatris
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 out-of-specification 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 PQS 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, downloadingand 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.
The minimum Qualifications for this role are;
Bachelor’s degree in Pharmacy or Science.
(1-2) years’ experience is preferred in a related area.
Good command of English language.
cGMP & cGLP knowledge is preferred with particular emphasis on Quality Control.
Knowledgeable with basic Laboratory instruments such as pH, Spectrophotometry, HPLC and reagent preparation.
Responsible for insuring that all results generated are in compliance with data integrity requirements.
Responsible for raising “NTM” Notification to Management whenever condition in PQS Q1213 applies.
Ability to use MS Office applications of MS Word, MS Excel, MS PowerPoint
Other Personal Qualifications
Excellent interpersonal, communication and presentation skills.
Demonstrate ability to work independently.
Excellent documentation and technical writing skills.
Good communications skills and able to work in a team and be able to interact with various priorities.
Active, organized and planner with high attention for details.
Ability to work under stress and meet deadlines.
High observation skills.
Active listening.
Time management skills.