Computer System Validation Manager

Vor 6 Tagen


Munich, Bayern, Deutschland SciPro Vollzeit

About SciPro

SciPro is a pioneering pharmaceutical company dedicated to developing innovative medications for the treatment of chronic pain. Our focus is on advanced manufacturing processes and creating novel medications.

Job Summary

We are seeking a highly skilled Computer System Validation Manager to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the validation and qualification of our computer systems, as well as implementing and optimizing validation processes.

Key Responsibilities

  • Review, approve, and track deviations, changes, and CAPAs, including risk assessments
  • Create and review SOPs, validation/qualification plans, and reports
  • Monitor and review product quality on an ongoing basis, with annual reviews
  • Execute Computer System Validation
  • Implement and optimize validation processes
  • Approve and qualify new suppliers
  • Handle complaints

Requirements

  • Degree in Pharmacy, Chemistry, Engineering, Pharmaceutical Engineering, or related field with strong knowledge in Quality Assurance and Software Validation
  • At least 3 years of professional experience in the pharmaceutical industry within a GMP-regulated environment
  • Excellent self-management and organizational skills
  • Strong team and communication skills
  • High degree of flexibility and commitment
  • Fluency in German (C1)


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