Senior Quality Assurance Associate( IPC) At Viatris
Full Job Description
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 Quality Assurance Associate - IPC ) role will make an impact:
Position Summary:
Carrying out in-process control function in production area.
Responsible for supervision of GMP practice in Production area.
Ensure that GMP standards, as they apply to the individual products and the site, are in compliance with Viatris and regulatory standards.
Key responsibilities for this role include:
Responsible/Backup for coordinating the daily schedule for IPC activities.
Inspect Production Lines/areas for cGMP compliance.
Conduct Production walkthrough to ensure following GMP
Sampling and testing of product during manufacturing, filling or packaging according to approved sampling plans.
Sampling of blend &/or finished goods for QC release testing according to approved SOPs.
Collection of retained samples.
Complete and maintain quality and production records according to cGMP.
Inspecting & approving the rejects of the in-process materials.
Accountable for QTS actions (CCR/QARs/Interims, etc.).
Accountable for investigations (LIR & QARs)
Reviewing Batch records & lab related records.
Accountable for supervision of Vendor related activities (Equipment qualification /maintenance /repairs).
Accountable for purchasing of IPC consumables.
Supervision of IPC activities
Act as IPC section Head Delegate in his absence.
Accountable for authoring quality related documentation (SOPs, Controlled documents, Risk assessments, Standard testing procedures, …etc.).
Sampling of production equipment’s after production shutdown activity.
Responsible 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.
Must be willing to back up for working Night shifts & other day shifts all as well over the year
The minimum qualifications for this role are:
At least 3 years’ experience in Quality Operations with proven success records including handling of complex issues with Production & engineering.
Good command of English both written and spoken.
Knowledgeable with interpersonal learning.
Good communication, teaching and coaching skills.
Decision-making skills.
Good planning and organization skills