Senior Quality Control Analyst (Stab.&Method.)

Viatris Egypt S.A.E

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.
 

Every day, we rise to the challenge to make a difference and here’s how the (QC Stability and Methodology Senior Analyst) 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.

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Job Specific technical/Functional/Professional Competencies:

 

▪ 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 Notification of critical quality events whenever condition in Viatris Policies 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 outsources 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 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 ensure following up ALCOA principles all over operations.

▪ Responsibility for compliance with Viatris Quality Standards.

▪ 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.

 

Experience and Knowledge

Ø  Bachelor’s degree in pharmacy or scientific background.

Ø  Previous experience in a laboratory environment.

Ø  Sound knowledge in general laboratory safety aspects.

Ø  Good understanding of the pharmaceutical regulatory process.

 

Essential Personal Qualifications

·       Bachelor’s degree in pharmacy or science.

·       Good command of English language.

·       Excellent interpersonal, communication and presentation skills.

·       Demonstrated ability to work independently.

·       Excellent documentation and technical writing skills.

·       Good communications skills and ability to work in a team, interact with various priorities and meet deadlines.

·       Active, organized and planner with high attention to details.

·       High observation skills.

·       Self-motivated and able to consistently meet timelines.

·       Ability to use MS Office applications of MS Word, MS Excel, MS PowerPoint

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.