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Operation Quality Section Head

gsk

جديد
Onsite Senior 🇬🇧 English
GMP cGMP GLP QMS CAPA Batch Release SAP

وصف الوظيفة

About the role

GSK is hiring an Operation Quality Section Head, a fully on-site role supervising operational quality (OQ) activities linked to the release of manufactured batches. The role ensures compliance with Good Manufacturing Practices (GMP), corporate quality standards and local and international regulations, and drives quality systems, deviation investigations, audit readiness and quality oversight across the Value Stream.

Key responsibilities

  • Drive quality culture and define the scope and risk-based frequency of Quality Oversight across manufacturing, processing, packaging and supporting functions, supervising OQ Officers and evaluating oversight effectiveness.
  • Ensure compliance with site QMS, GMP, GMS and regulatory requirements.
  • Lead deviations, OOS/OOT investigations, complaints, CAPAs, quality incidents, rework and reprocessing, and monitor site KPIs, quality trends and Quality Improvement Programs.
  • Prepare periodic quality performance and system reviews for the Site Quality Council, review quality risk assessments, validation documents and product lifecycle activities, and manage product quality incidents.
  • Oversee batch release and authorized person batch release, reviewing batch documentation (BMRs, BPRs, specifications, BOMs) and reporting conformance to the release plan in SAP.
  • Lead, coach and develop direct reports, build cross-functional partnerships and manage a diverse team with effective budgetary control.

Required profile

  • University degree in Pharmacy or scientific disciplines.
  • At least five years of experience in Quality Assurance or operational roles in the pharmaceutical industry.
  • Previous people management experience.
  • Fluency in English and Arabic, written and spoken.
  • Experience managing diverse teams and controlling budgets against agreed targets.

Required skills

  • Knowledge of current GMP, EDA regulatory requirements and the QMS system.
  • Familiarity with IQ, OQ, PQ, facility, utilities and equipment, and strong experience in cGMP/GLP compliance.
  • Excellent documentation, report writing and computer skills.
  • Problem-solving, critical thinking, prioritization and communication skills.

Questions fréquentes

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Source : ats:workday

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