Senior Quality Control Analyst (Finished goods) At Viatris
Position summary:
Conduct routine and non-routine analyses and relevant documentation and reporting.
Performance of lab-related 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 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.
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.
Ensuring QC compliance by closing all related actions, internal audit actions, MOH actions and data integrity actions.
Acts as a designee for QC Section Head, chemical finished goods lab for his different tasks.
QC Batch release acting as the QC section head designee.
Contacting vendors for all issues related to instruments, their offers, maintenance, calibration and or validation.
Delegate for Finished goods Section Head in case of his absence (if needed).
Delegate Quality Control Specialist (Chemical) in case of absence.
The minimum qualifications for this role:
Bachelor’s degree in Pharmacy or Science.
3-5 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.
cGMP & cGLP knowledge is preferred with particular emphasis on Quality Control.
Knowledgeable with Laboratory instruments such as pH, Spectrophotometry, HPLC and reagent preparation.
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.
Hard worker & self-motivated.