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Quality Assurance Compliance Specialist

Rameda
Giza, Egypt
Posted 5 years ago
137Applicants for1 open position
  • 71Viewed
  • 0In Consideration
  • 9Not Selected
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Job Details

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Job Description

  • Responsible for ensuring compliance with local regulations & ISO Standards.
  • Ensure and monitor adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection.
  • Provides general quality oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.
  • Perform random verifications of routine operational requirements, both on a product/batch level as well as on a process level.
  • Responsible for driving product quality improvements by coordinating investigations and corrective actions with all operating units, QA, Site Services, and suppliers to determine root causes and corrective actions to resolve complex, compliance related issues.
  • Evaluation and decision of deviations reports in compliant with cGMP guidelines and SOPs, while escalating the decision for critical /major deviations to quality management.
  • Actively participates in process improvement teams/initiatives. Records, Participate in or lead external audits, as needed.
  • Participate in all Change Control activities; reviews and follow up.

Job Requirements

  • Pharmacy graduate is a must
  • At least 3 years experience in the same position
  • Pharmaceutical industry is a must
  • Experience in sterile is a plus

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