Senior Quality Control Analyst - Raw Material At Viatris Egypt

Key responsibilities for this role include:

Sampling and performing all physical and chemical tests of raw materials in a timely manner.
Performing the raw material section related documentation.
Preparing and executing the raw material section SOPs and reporting all deviations.
Participate in Method validation for new or old products to be submitted to regulatory.
Keeping the inventories related to the sampling room tools and raw section chemicals.
Review of Production orders.
Participate in instruments calibration.
Implementing the PQS requirements regarding the raw section laboratory.
Performing all required training for different activities.
Stick to CGMP and safety procedures in the all activities.
Working on improving his process by implementing lean and 6σ projects
Deal with different instruments (HPLC, NIR, UV, etc.)
Participate in out-of-specification and failure investigations.
Supply quality control data necessary for regulatory submissions.
Calibration of raw section laboratory equipment and completion of periodic reviews according to required frequency.
Responsible for ensuring that all results generated are in compliance with data integrity requirements.
Responsible for raising “NTM” Notification to Management whenever condition in PQS Q1213 applies.
Participate in out-of-specification and failure investigations through LIRs / QARs.
Supply quality control data necessary for regulatory submissions.
Routine checking of laboratory documentation and calculations to ensure completeness and accuracy of data.
Always ensuring authorized written procedures are followed accurately.
Update of controlled documents as required.
Responsible Maintain high standards of cleanliness, tidiness and organization of work areas at all times.
Maintain all training at an acceptable level through the use of the Learning Management System.
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.
Delegate for (Incoming materials & Artwork) Section Head in case of his absence (if needed).
Delegate Quality Control Specialist (Raw Material) in case of absence.

The minimum qualifications for this role are:

Bachelor’s degree in Pharmacy or Science.
(2-4) 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.
Excellent interpersonal, communication and presentation skills.
Excellent documentation and technical writing skills.
Active, organized and planner with high attention for details.
High observation skills.
Ability to use MS Office applications of MS Word, MS Excel, MS PowerPoint.
Highly motivated towards achievement and task oriented.
Time management skills.

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