Senior Quality Control Analyst (Stability &Methodology) At Viatris Egypt
Key responsibilities for this role include:
Responsible for the QC laboratory functions (Stability, & method validation) and the corresponding documentation to support the timely disposition of product.
Responsible for ensuring that all results generated are in compliance with data integrity requirements.
Responsible for fulfilling all regulatory requirements related to stability and methodology.
Follow laboratory procedures and practices in accordance with company policy and regulatory requirements.
Performing RFT projects for M1, M2, and M3.
Participate in stability out-of-specification and failure investigations.
Supporting outsource manufacturing department by sending stability samples on time, evaluation of stability results and taking any immediate actions required in addition to archiving of these results..
Responsible for creation/reviewing of stability schedule, protocols, reports and trends.
Responsible for following up stability equipment calibration & maintenance and ensure appropriate documentation and archiving
Participate in internal audit program as auditor.
Responsibility for implementation of Data integrity program in the relevant work area
The minimum qualifications for this role are:
Bachelor’s degree in Pharmaceutical Sciences.
Minimum 3 years of relevant experience in QC functions.
Good command of English in both written and spoken.
Excellent in Microsoft office (word, excel & PowerPoint).
Knowledgeable with interpersonal learning.
Communication, teaching and coaching skills.
Logical way of thinking.
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.