Quality Control Analyst (Stability and Methodology)
Essential Personal Qualifications:
– Bachelor’s degree in pharmacy or science.
– 1-5 years’ experience in a related area.
– Excellent documentation and technical writing skills.
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.
Execute all activities related to process, cleaning, and instrument validation.
Prepare and execute the SOPs, calibration, and validation documents (IQ, OQ & PQ) related to chemical laboratory tasks.
Using, monitoring, and controlling of laboratory chemical reagents inventory and expiry
Perform Data loggers monitoring, downloading, and reviewing.
Knowledgeable with basic Laboratory instruments such as pH, Spectrophotometry, HPLC and reagent preparation.
Raise “NTM” Notification 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 QARs 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)
cGMP & cGLP knowledge is preferred with particular emphasis on Quality Control.
Knowledgeable with Laboratory instruments such as pH, Spectrophotometry, HPLC and reagent preparation.
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