Data by YubHub
Quality Oversight Supervisor
GSK
Sponsorship not confirmed
You apply on the original listing. Flieva never charges you to apply and never asks for payment for a job.
About the job
GSK · Cairo, Egypt · onsite We are seeking a Quality Oversight Supervisor to supervise OQ activities related to the release of manufactured batches, ensuring compliance with Good Manufacturing Practices (GMP), Corporate Quality Standards, and local/international regulations. Key Responsibilities: Drive and strengthen quality culture across all value stream operations. Define and maintain the scope and risk-based frequency of Quality Oversight activities across manufacturing, processing, packaging, and supporting functions. Supervise OQ Officers in executing routine oversight activities and ensuring GMP compliance. Monitor oversight coverage, execution, overdue activities, and related actions. Evaluate oversight effectiveness and drive continuous improvement. Ensure implementation and compliance with site QMS, GMP, GMS, and regulatory requirements. Quality Systems & Performance Management: Lead and oversee deviations, OOS/OOT investigations, complaints, CAPAs, quality incidents, rework, and reprocessing activities, ensuring robust investigations and timely closure. Drive quality performance improvement through monitoring of site KPIs, quality trends, periodic system reviews, and Quality Improvement Programs (QIPs). Prepare and present periodic quality performance and system reviews to the Site Quality Council. Review and approve relevant quality risk assessments, product lifecycle activities, validation documents, and periodic product reviews. Manage and coordinate product quality incidents with relevant site quality functions. Drive inspection readiness through GEMBAs, SLE activities, and support of GPS foundations. Escalate critical quality issues and ensure effective resolution. Batch Release & Authorized Person Responsibilities: Oversee and perform batch release activities for manufactured and packaged products, ensuring full GMP and regulatory compliance. Review and approve batch documentation, including BMRs, BPRs, specifications, BOMs, and relevant quality records. Ensure completion and assessment of all required manufacturing, QC, sampling, testing, change control, and deviation activities before batch release. Perform Authorized Person batch release activities and relevant ERP transactions, including release, rework, and rejection decisions. Oversee AP delegate qualification, where applicable. Monitor and report conformance to release plan and maintain accurate SAP quality-related data. Leadership & Team Development: Lead, coach, and develop direct reports, ensuring appropriate technical competencies, training, and qualifications. Monitor team performance and promote accountability, collaboration, and continuous improvement. Build effective cross-functional partnerships to achieve site quality objectives. Requirements: University Degree in Pharmacy or Scientific disciplines. Minimum five years of experience in Quality Assurance, or Operational roles within the Pharmaceutical industry. Previous people management experience. Fluency in English and Arabic (both written and spoken). Key Capabilities and Skills: Up to date knowledge of current GMP, EDA Regulatory requirements, QMS System. Excellent documentation, report writing skills, and computer skills. Excellent verbal and written communication skills. Excellent problem solving and critical thinking capabilities. Strong prioritization and organization skills. Familiar with IQ, OQ, PQ, facility, utilities, Equipment and Strong experiences in cGMP/GLP compliance activities. Self-motivation, empowerment and adaptation to business changes. Able to demonstrate experience of managing diverse teams of professional staff and effective budgetary control against agreed targets.
More jobs like this
Engineering Manager, Agent Security PartnershipsAnthropicNew York City, NY | Seattle, WA; San Francisco, CA | New York City, NY · United StatesSponsorship stated in listingAccountantn8nGermanySponsorship stated in listingProduct Manager, Seller ExperienceAnthropicSan Francisco, CA | New York City, NY · United StatesSponsorship stated in listingSecurity Engineer, RF and Technical Surveillance CountermeasuresAnthropicSan Francisco, CA | New York City, NY · United StatesSponsorship stated in listing
Flieva