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QC Supervisor

QC Supervisor

Tabuk PharmaceuticalsSaudi Arabia
منذ يوم 1
الوصف الوظيفي

Laboratory Oversight & Operations

  • Supervise and coordinate daily QC testing activities in the raw materials section.
  • Plan, schedule, and distribute routine and non-routine work to meet release timelines.
  • Ensure timely analysis and approval of raw materials to support uninterrupted production.
  • Monitor laboratory housekeeping, safety, and adherence to EHS requirements.
  • Ensure availability, calibration, and qualification of instruments used in raw material analysis (FTIR, Raman, UV, HPLC, GC, wet chemistry, etc.).

Review, Approval & Data Integrity

  • Review and approve raw data, analytical results, specifications, COAs, and test reports.
  • Ensure compliance with ALCOA+ data integrity principles across all records and systems.
  • Approve results and transactions in SAP / LIMS and maintain vendor-related data.
  • Conduct trend analysis of water and raw material testing results to identify patterns.
  • Maintain and periodically review the raw material vendor approval list.

    • Quality & Compliance

  • Ensure adherence to cGMP, GLP, GDP, ICH, USP / EP requirements, and internal SOPs.
  • Participate in internal / external audits (FDA, EMA, SFDA, WHO, etc.) and ensure inspection readiness.
  • Investigate and document OOS, OOT, deviations, and non-conformances, ensuring timely closure with effective CAPAs.
  • Support and monitor the implementation of the Quality Management System (QMS).
  • Participate in supplier qualification and requalification, including vendor audits and COA verification.

    • Documentation & SOP Management

  • Oversee the preparation, review, issuance, and periodic revision of SOPs, logbooks, and templates.
  • Ensure all QC documentation is controlled, accurate, and traceable.
  • Prepare and review analytical data reports and provide QC support for Regulatory Affairs submissions.
  • Ensure compliance with documentation requirements for data integrity and audit readiness.

    • People Management & Training

  • Lead, mentor, and evaluate QC analysts in the raw material section.
  • Ensure onboarding, technical training, and continuous development of staff are conducted and documented.
  • Conduct performance evaluations, succession planning, and conflict resolution as needed.
  • Foster a culture of quality, accountability, and continuous improvement among team members.
  • Ensure team readiness for audits by maintaining consistent training in data integrity and regulatory compliance.

    • Continuous Improvement & KPIs

  • Drive laboratory efficiency and continuous improvement initiatives (Lean, Six Sigma, digitalization).
  • Establish and monitor quality KPIs
  • Promote cost awareness and optimize resource utilization to increase efficiency.

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    إنشاء تنبيه وظيفي لهذا البحث

    Qc • Saudi Arabia