Quality Control Analyst (Raw Materials)

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 heres how the (Quality Control Specialist (Raw Material)) role will make an impact:

• Position summary:

• The Quality Control Raw Material Specialist is responsible for the sampling and analysis of raw material.

• Performing all relevant documentation.

• Performing different tasks within the raw section.

• The Quality Control Raw Material Specialist is expected to perform all duties in an efficient responsible and professional manner cooperating and contributing to the strategic goals of the company.

• Job Specific technical/Functional/Professional Competencies:

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 Viatris Policies 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 6 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.

Follow up calibration of raw section laboratory equipment.

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.

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

• 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 basic Laboratory instruments such as pH Spectrophotometry HPLC and reagent preparation.

Essential Personal Qualifications

• Bachelors degree in pharmacy or science.

• Excellent interpersonal communication and presentation skills.

• Excellent interpersonal communication and presentation skills.

• Ability to interact with various priorities with good communication with stakeholders.

• Demonstrated ability to work independently.

• Must be able to work in a stressful on-demand environment and be able to communicate under stress in a non-confrontational effective manner.

• Excellent documentation and technical writing skills.

• High attention to details analytical problem solving and good planning skills.

• Hard worker self-motivated with scientific and logical way of thinking.

• Time management with ability to meet deadlines and decision-making skills

At Viatris we offercompetitivesalaries benefitsandan 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.