Position summary:
- Carrying out in-process control function in production area.
- Responsible for supervision of GMP practice in Production area.
Job Specific technical/Functional/Professional Competencies:
- Responsible/Backup for coordinating the daily schedule for IPC activities.
- Inspect Production Lines/areas for cGMP compliance.
- Responsible for coordinating the weekly overtime shift for IPC Inspectors.
- 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.
- Supervision of IPC inspectors & activities.
- Accountable for QTS actions (CCR/QARs/Interims, etc.).
- Accountable for closing PQS gaps.
- 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.
- Accountable for authoring quality related documentation (SOPs, Controlled documents, Risk assessments, Standard testing procedures, …etc.).
- 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 Pfizer Quality Standards.
- Must be willing for working Night shifts & other day shifts all as well over the year according business needs.
Experience and Knowledge
- 1 – 3 years’ experience in Quality Operations with proven success records including handling of complex issues with Production & engineering
Essential Personal Qualifications
- Good command of English both written and spoken.
- Knowledgeable with interpersonal learning.
- Communication, teaching and coaching skills.
- Logic way of thinking.
- High analytical skills.
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