Quality Assurance IPC Inspector At Viatris
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.
Job Specific technical/Functional/Professional Competencies:
Responsible/Backup for coordinating the daily schedule for IPC activities.
Conduct the sampling plan and perform Visual inspections for each product lot according to scheduled routine inspections & Conduct required challenge tests.
Perform line clearance activities for production equipment’s.
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 reject of the in-process materials.
Accountable for QTS actions (CCR/Investigations/Interims, etc.).
Accountable for investigations (Incident & deviation)
Reviewing Batch records & IPC lab related records.
Accountable for supervision of Vendor related activities (Equipment qualification /maintenance /repairs).
Accountable for purchasing of IPC consumables.
Supervision of IPC activities.
Review & approve Retain store documents.
Accountable for authoring quality related documentation (SOPs, Controlled documents, Risk assessments, Standard testing procedures, …etc.).
Sampling of production equipment’s after production shutdown activity with validation team.
Responsible for implementation of Data integrity program in the relevant work area and insure following up ALCOA principles all over operations.
Responsibility for compliance with Viatris Quality Standards.
Must be willing for working Night shifts & other day shifts all as well over the year according business needs.
Delegate for Shift QA IPC Senior Associate or Senior Quality Assurance IPC Associate in case of his absence (if needed).
Experience and Knowledge:
A bachelor’s degree in scientific field or equivalent pharmaceutical experience.
From 1- 3 years’ experience with technical background in cGMP and Quality Operations and proven success records including handling of complex issues with Production & engineering.
Essential Personal Qualifications
Excellent in communication, planning, and coaching skills.
Decision-making based on a risk science-based approach.
Good command of English both written and spoken.
Knowledgeable with interpersonal learning.
Logic way of thinking with high analytical skills.
Good planning and organization skills.
Preferred Qualifications:
Six Sigma (Yellow belt).
Good knowledge of Trackwise modules & SAP system.
Experience in QC/QA/Quality Compliance.