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Operational Quality Officer

GSK

Posted on December 2, 2019

1 - 2 years Cairo - Egypt

Bachelor of Pharmacy(Pharmacy). Any Nationality

Opening 01

Job Description

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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, GQG 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 processes.
• Handle deviation, complaints and OOS 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.
job requirements
More than 1 year
Not Specified at least
Healthcare and Medical Services


Pharma / Biotech / Clinical Research

Quality / Testing / QA / QC / Inspector

Desired Candidate Profile

Knowledge/ Education / Previous Experience Required :
• Bachelor Pharmacy degree.
• Minimum one year of experience in similar field.
• Good level of English in terms of speaking, writing and reading.
• Computer Skills (Microsoft office).

Keywords

Operational Quality Officer

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GSK


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