Site Name: Egypt - Cairo
Posted Date: Aug 23 2022
Job Purpose Follow up adherence to OQ system and GMP in production areas, check batch-related documentation, and provide reports about quality performance against approved standards. Key Responsibilities:

• Revise Quality technical documents according to Corporate Standards, such as GQP’s, GQMP’s and FPG’s. 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 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 L1 and provide Quality inputs in CCRs.
• Support EHS & GPS implementation in managing different activities
• Ensure identification and rejection of non-conforming materials/products according to GMP standards.
• Responsible to participate in Self Inspection program within OQ department to confirm department adherence to LSOPs and policies.
• Easily the production process with meeting GSK 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 eject and reject Activities in VS areas.

Why you? Basic Qualifications:

• University graduate at the faculty of pharmacy.
• Up to date knowledge of current GMP, EDA Regulatory requirements, GSK QMS System.
• Excellent documentation and report writing skills.
• Excellent verbal and written communication skills.
• Familiar with IQ, OQ, PQ, facility, utilities, Equipment and Strong experiences in cGMP/GLP compliance activities.
• Good command of English (spoken and written)
• Good Computer and communication skills (Word and Excel)
• Knowledge of EHS and GMP requirements

Essential Skills and Abilities:

• Good command of English and computer skills.
• Self-motivation, empowerment and adaptation to business changes.
• Strong prioritization and organization skills.
• Able to demonstrate experience of managing diverse teams of professional staff and effective budgetary control against agreed targets.

Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
Contact information:
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