Operational Quality Officer At GSK 

  

A leading multinational pharmaceutical company based in cairo egypt is seeking a talented Operational Quality officer (willing to work in alternating shift pattern) for a temporary contract for approximate 12 months to support in a specific project.

You will be responsible for:

• Review Quality technical documents according to Corporate Standards policies. This includes batch manufacturing and packaging documents, specifications, SOPs and bills of materials.
• Ensure proper sampling of intermediate, bulk and finished product batches for routine testing, validation practices and cleaning samples.
• Follow up application of OQ measures in production areas and check compliance of in-process testing.
• Ensure application of OQ measures during validation batches and planned changes.
• Monitor calibration of production equipment and IPC testing instruments.
• Review batch related documentation for completeness, correctness and compliance to approved standards.
• Report any observed incidents during routine production and follow up its correction and corrective action.
• Ensure that GMP Standards are followed properly in the Lab, Utilities, Warehouse, Dispensing and manufacturing areas and during the manufacturing and packaging processes.
• Handle deviations, complaints and OOS & OOT in coordination with area owners and ensure implementation of CAPA and closure within required timeline.
• Team member in self-inspection and provide Quality inputs in CCRs.
• Ensure identification and rejection of non-conforming materials/products according to GMP standards.
• Responsible to participate in Self Inspection program within the department to confirm department adherence to LSOPs and policies.
• Simplify the production process with meeting quality standards
• Coaching operators to ensure that quality mindset is embedded in their day to day activities.
• Handling PCCE incidents in the VS Areas.
• Responsible for and ensure proper implementation of ALCOA+ principles
• Ensure proper handling of eject and reject Activities in VS areas.

The Qualification required for this role is:

• 1-3 years of Job-Related Experience required: University graduate, pharmacy or science.
• Up to date knowledge of current GMP, EDA Regulatory requirements, QMS System.
• Excellent documentation and report writing skills.
• Excellent verbal and written communication skills.
• Strong experiences in cGMP/GLP compliance activities.
• Good command of English (spoken and written)
• Good Computer and communication skills (Word and Excel)
• Knowledge of GMP requirements

For interested candidates please send the CV at nouran.moahmed@gmail.com

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