Jobs / Egypt / Glaxosmithkline LLC

Glaxosmithkline LLC

Operational Quality Officer

Egypt - Cairo Posted today

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Skills this job asks for

ComplianceWarehouse operationsPharmacyCommunicationExcelArabicEnglish

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About the role

Scope: Ensure adherence to GMP standards and procedures through independent oversight of GMP processes. Improve the effectiveness of quality in preventing, identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. Maintain presence and be accountable for key quality decision-making or quality escalations. Provide first line support to operational (for example: rapid response to quality issues, provide guidance and coaching) and maintain inspection-readiness through independent checks for both Vs and Non Vs processes. Review/check Quality-related documentation, and provide reports about quality performance against approved standards. Key Responsibilities: In this role, you will be responsible for the following: • GMP Compliance & Oversight: Ensure all GMP processes and personnel adhere to current procedures minimising risk of non-compliance and always maintaining inspection readiness Maintain a visible presence across GMP operational areas to support quality issue management. Accountable for key quality decision making across activities such as the initial impact assessment for deviations Conduct spot-checks in Vs and Non VS areas, for example production, warehouse, utilities, and laboratory areas. Ensure adherence to the Quality Oversight program for both VS and Non VS areas and ALCOA+ documentation principles. Cover oversight shifts Monitor facility housekeeping standards and escalate deviations promptly. Oversee the durability and rightness of related risk assessments and quality systems as LC, PCCE, Eject & reject, IPC frequency, …etc. Accountable to manage the rework and reprocess within the site when needed as per QMS requirements. • Documentation & Technical Review: Review/ approve quality documents (SOPs, master batch records, BOMs…etc) Review batch documentation for completeness and compliance with approved standards prior to product release • Sampling, Testing & Validation: Ensure proper sampling of Retained finished product batches Oversee OQ measures during Routine & validation batches and engineering changes • Deviation & Incident Management: Act as QA reviewer in deviations with lead investigator to ensure RCA identification and proper line of sight Handle customer complaints investigations and ensure proper line of sight Report and follow up on incidents/deviations observed during routine production • Quality Culture & Training: Responsible for the delivery of Stop for Quality topics Foster a “Quality Starts With Me” culture through coaching and awareness Foster Oversight culture across Vs and Non VS areas. • Cross-functional Support: Provide quality input during management monitoring and quality systems( CCRs, Deviations, Customer compliant…etc): Support EHS and GPS implementation across various activities. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: • University Degree in Pharmacy. • A minimum of one-year experience in the pharma industry. • Up to date knowledge of current GMP, EDA Regulatory requirements, GSK QMS System. • Excellent documentation and report writing skills. • Validation knowledge and strong experience in cGMP/GLP compliance activities. • Good Computer and communication skills (Word and Excel). • Knowledge of EHS and GMP requirements. • Fluent in Arabic and English (both written and spoken). Soft Skills: • Excellent verbal and written communication 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. This role is fully on site and requires working on a

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