Quality Control Analyst

6 months ago

مصر, Egypt Viatris Full time

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 (Quality Control Analyst (Raw Material)) role will make an impact:
Job Description and tasks:

- 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 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 insuring 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

Experience and Knowledge:

- cGMP & cGLP knowledge is preferred with particular emphasis on Quality Control.
- Knowledgeable with basic Laboratory instruments such as pH, Spectrophotometry, HPLC and reagent preparation.

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 able to work in a team and be able to interact with various priorities.
- Active, organized and planner with high attention for details.
- Ability to work under stress and meet deadlines.
- High observation skills.
- Hard worker & self-motivated.

Preferred Qualifications:

- Minimum 1 to 2 years Industry/GMP experience is preferred in a related area.
- Highly motivated towards achievement and task oriented.
- Ability to effectively organize and manage personal work schedule semi-independently.
- Active listening.
- Hard worker & self-motivated.
- Time management 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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