MEVAC
رجوع
دوام كاملوظائف مكتبية

IPC Supervisor

MEVAC - Facility ( El-Salhya El-Gedida)Quality Assuranceمن مقر العمل
قدّم الآن

الوصف الوظيفي

The IPC Supervisor is responsible for overseeing and ensuring the effective implementation of Quality Assurance activities throughout manufacturing operations. The role ensures that in-process activities, manufacturing documentation, line clearance, cleaning verification, filling, and packaging processes comply with approved procedures, company requirements, EU GMP guidelines, and applicable quality standards. The position is also responsible for coordinating deviation investigations, CAPA follow-up, change control activities, and the supervision and development of QA Inspectors to maintain product quality, patient safety, and GMP compliance.

المسؤوليات

  • Lead and oversee all QA activities within Technical Operations, ensuring compliance with approved procedures, cGMP, EU GMP, and company guidelines.
  • Ensure line clearance, cleaning checks, production documentation review, batch record review, and batch release activities.
  • Review live vaccine batch records as first reviewer and follow up on required corrections and documentation discrepancies.
  • Follow up on filling and packaging processes, retained samples, environmental monitoring (EM), and differential pressure (ΔP) across relevant areas.
  • Review and analyze production and quality data from standard checklists and batch activities to ensure compliance.
  • Implement and follow up on Change Control, Deviation, CAPA, and investigation activities, ensuring timely closure.
  • Conduct process observations and internal inspections and identify quality or GMP compliance gaps.
  • Review departmental SOPs from a scientific and technical perspective and ensure alignment with EU GMP requirements.
  • Ensure compliance with applicable EU GMP, ISO standards, QHSE policies, and site quality requirements
  • Supervise, guide, and support QA personnel and perform assigned responsibilities under the Emergency Plan.
  • Perform other quality-related duties as assigned by the Operational Quality Section Head.

المتطلبات

Education

  • Bachelor’s degree in Science, or Veterinary Medicine.
  • Knowledge of QHSE, cGMP, and Biorisk Management Systems.

Experience

  • Minimum 4 years of relevant experience in the pharmaceutical or biopharmaceutical industry.

Technical Knowledge

  • Cleanroom Practices
  • Equipment Lifecycle Management
  • Batch Record Management
  • Deviation Management
  • Product Quality Review (PQR)
  • Aseptic Process Simulation / Media Fill
  • Change Control Management

Technical knowledge of:

  • EU GMP Annex 1
  • ISO 17025:2017
  • ISO 9001:2015 – Quality Management System
  • GMP Fundamentals

Skills & Competencies

  • Good computer skills and ability to work with quality documentation and systems.
  • Strong leadership, training, and team supervision skills.
  • Good English communication skills.
  • Strong mathematical and calculation skills.
  • Self-motivated, detail-oriented, and able to work effectively in a regulated manufacturing environment.

المزايا

  • Social, Medical and Life Insurance
  • Pension Coverage
  • Profit Share
  • Quarterly Balanced Scorecard
  • Transportation from certain points
قدّم على هذه الوظيفة