Validation Analyst

Want to Expand your career-development potential, your ability to help donors and patients, and your access to professional opportunities?

We’re growing fast. [You can, too!] There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you’re someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a:

• Adheres to company validation standards, procedures, policy and guidelines of validation process.
• Performs test case execution of GxP computerized systems (hardware, software, and regulated reports) validation protocols and documents consistent with Good Automated Manufacturing Practice (GAMP) and Blood Establishment Computer System (BECS) guidelines.
• Performs test case execution of non-GxP computerized systems validation protocols and documents.
• Performs test case execution of equipment validation protocols and documents consistent with good engineering practices and current Good Manufacturing Practices (cGMP), including: donor center processing, equipment, freezers, refrigerators, temperature mapping of rooms and equipment.
• Performs test case execution of non-regulated report validation protocols and documents consistent with good engineering practices and current Good Manufacturing Practices (cGMP).
• Performs the execution of process validation protocols and documents consistent with FDA and EU guidelines.
  
  Evaluates validation results and provides updates to QA Validation Supervisor.
• Performs the assessment of product involved in temperature excursions.

We’re growing fast. [You can, too!] There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you’re someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a:

• Adheres to company validation standards, procedures, policy and guidelines of validation process.
• Performs test case execution of GxP computerized systems (hardware, software, and regulated reports) validation protocols and documents consistent with Good Automated Manufacturing Practice (GAMP) and Blood Establishment Computer System (BECS) guidelines.
• Performs test case execution of non-GxP computerized systems validation protocols and documents.
• Performs test case execution of equipment validation protocols and documents consistent with good engineering practices and current Good Manufacturing Practices (cGMP), including: donor center processing, equipment, freezers, refrigerators, temperature mapping of rooms and equipment.
• Performs test case execution of non-regulated report validation protocols and documents consistent with good engineering practices and current Good Manufacturing Practices (cGMP).
• Performs the execution of process validation protocols and documents consistent with FDA and EU guidelines.
• Evaluates validation results and provides updates to QA Validation Supervisor.
• Performs the assessment of product involved in temperature excursions.

• Adheres to company validation standards, procedures, policy and guidelines of validation process.
• Performs test case execution of GxP computerized systems (hardware, software, and regulated reports) validation protocols and documents consistent with Good Automated Manufacturing Practice (GAMP) and Blood…