Description
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.
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