Senior Quality Control Analyst (Finished 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, 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 PQS 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 are:
cGMP & cGLP knowledge is preferred with particular emphasis on Quality Control.
Knowledgeable with basic Laboratory instruments such as pH, Spectrophotometry, HPLC and reagent preparation.
Bachelor’s degree in pharmacy or science.
(2-4) years’ experience is preferred in a related area.
Good command of English language.
Excellent interpersonal, communication and presentation skills.
Demonstrated ability to work independently.
Must be able to work in a stressful, on-demand environment and be able to communicate under stress in a non-confrontational, effective manner.
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.
High observation skills.
Hard worker & self-motivated.
Ability to use MS Office applications of MS Word, MS Excel, MS PowerPoint
Highly motivated towards achievement and task oriented.
Ability to effectively organize and manage personal work schedule semi-independently.
Hard worker & self-motivated.
Time management skills.