Senior Quality Control Analyst

2 weeks ago


مصر, Egypt Viatris Full time

3803 Viatris Egypt S.A.E

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the (Senior QC Analyst/Stability and Methodology) role will make an impact:
Position summary:
Responsible for the QC laboratory functions (Stability & Methodology) and the corresponding documentation to support the timely disposition of product.

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 raising “NTM” Notification to Management whenever condition in PQS Q1213 applies.
- 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.
- Maintains laboratory supplies inventory required for Stability analysis.
- Responsible for handling the global changes affecting stability and methodology.
- Supports QA with all CCRs and QARs related Stability & Methodology.
- Responsible for performing all method validation activities required.
- Responsible for creation/review of method validation protocols and reports.
- 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.
- Quality Control Stability and Methodology Section Head.
- Delegate for Quality Control Stability and Methodology Section Head in case of his absence (if needed).
- Delegate Quality Control Stability and Methodology specialist in case of absence.

The minimum qualifications for this role are:

- Bachelor’s degree in Pharmacy or Science.
- 2-4 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.
- Excellent interpersonal, communication and presentation skills.
- Demonstrated ability to work independently.
- Ability to work in an on-demand environment and communicate 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.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.



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