Quality Control Analyst

2 days 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 QC Analyst role will make an impact;

Position Summary;

Conduct routine and non-routine analyses and relevant documentation and reporting,

Performance of lab-related tasks.

Key Responsibilities for this role include:

- Conduct routine and non-routine analyses of in-process materials, finished goods, or stability samples in a timely manner.
- Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
- Conduct chemical or physical laboratory tests in making qualitative or quantitative analyses
- Complete documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
- Write technical reports or prepare graphs or charts to document experimental results.
- Calibrate, validate, or maintain laboratory equipment.
- Participate in out-of-specification and failure investigations and recommend corrective actions.
- Supply quality control data necessary for regulatory submissions.
- Investigate or report questionable test results.
- Addition and withdrawal of stability samples from stability chambers
- Performance of data entry and trend analysis
- Reviewing, filing, reporting and trending of stability data
- Perform the Analytical Method Transfer Exercise (AMTE) for the new test procedures required for manufacturing of new product in our site.
- Perform Validation required for the new developed test procedures.
- Execute all activities related to process, cleaning and instrument validation.
- Preparing and executing the SOPs, calibration and validation documents (IQ, OQ & PQ) related to chemical laboratory tasks.
- Implementing the PQS requirements regarding the chemical laboratory
- Using, monitoring and controlling Reference standards inventory and expiry
- Using, monitoring and controlling of expiry and inventory of laboratory stock items including reagents, glassware, filters, etc.
- Perform Data loggers monitoring, downloading and reviewing.
- Writing and revision of Quality Control SOP’s
- Working on improving his process by implementing lean and 6σ projects.
- 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.

The minimum qualifications for this role are:

- Bachelor’s degree in Pharmacy or Scientific background
- High physical and technical skills
- Good command of English language
- High observation skills
- Familiar with MS Word, MS Excel and basic statistics (mean, SD, %RSD).
- cGMP & cGLP knowledge is preferred with particular emphasis on Quality Control.
- Knowledgeable with basic Laboratory instruments such as pH, Spectrophotometry, HPLC and reagent preparation.
- 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.

Preferred Qualifications:

- Two (2) years’ 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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