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GSK

Develops medicines, vaccines, and consumer health

Operational Quality Officer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeCairo, Cairo Governorate, EgyptNo salary listed

About the Job

Requirements

  • A University Degree in Pharmacy.
  • A minimum of one year of experience in the pharmaceutical industry.
  • Up-to-date knowledge of current Good Manufacturing Practice (GMP), Egyptian Drug Authority (EDA) regulatory requirements, and the GSK Quality Management System (QMS).
  • Excellent documentation and report-writing skills.
  • Validation knowledge and strong experience in current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) compliance activities.
  • Good computer skills, including Word and Excel.
  • Knowledge of Environment, Health and Safety (EHS) and GMP requirements.
  • Fluency in written and spoken Arabic and English.
  • The ability to demonstrate experience managing diverse teams of professional staff and effective budgetary control against agreed targets.

Responsibilities

  • Ensure all GMP processes and personnel adhere to current procedures, minimize non-compliance risk, and maintain inspection readiness.
  • Maintain a visible presence across GMP operational areas to support quality issue management.
  • Make key quality decisions across activities, including initial impact assessments for deviations.
  • Conduct spot-checks in Vs and Non-Vs areas, including production, warehouse, utilities, and laboratory areas.
  • Ensure adherence to the Quality Oversight program in Vs and Non-Vs areas and to ALCOA+ documentation principles.
  • Cover oversight shifts.
  • Monitor facility housekeeping standards and promptly escalate deviations.
  • Oversee the adequacy and accuracy of related risk assessments and quality systems, including LC, PCCE, Eject & Reject, and IPC frequency.
  • Manage site rework and reprocessing when needed in accordance with QMS requirements.
  • Review and approve quality documents, including SOPs, master batch records, and BOMs.
  • Review batch documentation for completeness and compliance with approved standards before product release.
  • Ensure proper sampling of retained finished-product batches.
  • Oversee OQ measures during routine and validation batches and engineering changes.
  • Act as QA reviewer in deviations alongside the lead investigator to ensure root-cause analysis identification and proper line of sight.
  • Handle customer complaint investigations and ensure proper line of sight.
  • Report and follow up on incidents and deviations observed during routine production.
  • Deliver Stop for Quality topics.
  • Promote a “Quality Starts With Me” culture through coaching and awareness.
  • Promote an oversight culture across Vs and Non-Vs areas.
  • Provide quality input during management monitoring and quality systems, including CCRs, deviations, and customer complaints.
  • Support EHS and GPS implementation across various activities.

About the Company

GSK

Develops medicines, vaccines, and consumer health

GSK is a global healthcare company focused on three main areas: Pharmaceuticals, Vaccines, and Consumer Healthcare. It develops medicines, vaccines, and consumer health products to improve health outcomes worldwide. Its products address diseases in respiratory, HIV, oncology, and immuno-inflammatory areas; vaccines for influenza, shingles, and COVID-19; and over-the-counter wellness products. The company relies on substantial R&D and strategic partnerships to bring new products to market and to address health needs. Revenues come from sales of medicines, vaccines, and consumer health items, often complemented by patient support programs and collaborations with governments and biotech partners.

Company size
10,001+
Company stage
IPO
Headquarters
London, United Kingdom
Founded
1891

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