Qureos

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Sr. Quality Operations Coordinator

Gebze, Turkey

Job Description

Major accountabilities:

  • Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
  • Support exception investigations
  • Review and approval of production, QC, and AS and T records
  • MBR review
  • Support OpEx improvement projects Qualified Person
  • Executes batch release in compliance with registration
  • Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt
  • Distribution of marketing samples (where applicable)

Key Performance Indicators

  • On-time and GMP-compliant release of dosage forms
  • No Complaints about inspections by authorities in your own area of responsibility without these being noticed and communicated beforehand.
  • Successfully Support continuous improvement Projects
  • Executes batch release in compliance with registration

Minimum Requirements

Work Experience:

  • Critical Negotiations.
  • Functional Breadth.
  • Project Management.
  • People Leadership.
  • Collaborating across boundaries.
  • Operations Management and Execution.

Skills

  • Continuous Learning.
  • Dealing With Ambiguity.
  • Employee Performance Evaluations.
  • Gmp Procedures.
  • People Management.
  • QA (Quality Assurance).
  • Quality Control (QC) Testing.
  • Quality Standards.
  • Self-Awareness.
  • Technological Expertise.
  • Technological Intelligence.

Languages

  • English.

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