Validation Manager

3 weeks ago


Charlotte, North Carolina, United States Octapharma Plasma Full time

About the Role:

Octapharma Plasma is seeking a highly skilled Validation Manager to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the accuracy and reliability of our equipment validation processes.

Key Responsibilities:

  • Develop and maintain equipment validation policies and procedures in accordance with regulatory requirements.
  • Perform process validation protocols and documents consistent with FDA and EU guidelines.
  • Ensure regulatory requirements are met during development of equipment validation protocols.
  • Develop and maintain donor center freezer, refrigerator, and Anti-D refrigerator validation protocols to be executed fleetwide.
  • Develop and maintain donor center supply room temperature mapping protocols to be executed fleetwide.
  • Develop and maintain laboratory freezer and refrigerator validation protocols.
  • Develop and maintain plasma storage warehouse freezer and processing area validation protocols.
  • Analyze and interpret validation and study data to determine if requirements are met.
  • Review and approve executed equipment validation testing protocols.
  • Develop equipment validation summaries to support executed protocol and address deviations found during execution.
  • Perform deviation investigations identified during the equipment validation process and ensure timely resolution of all nonconformities.
  • Support entire fleet of donor centers through meeting established SLA requirements when responding to requests.
  • Support laboratory and plasma storage warehouse through meeting established SLA requirements when responding to requests.
  • Manage support ticket documentation and statuses through to closure.

Requirements:

  • Bachelor's degree in IT, life science or related field required.
  • Three years' experience in biologics, drug manufacturing, or medical device industry or FDA regulated laboratory required.
  • Minimum of two (2) years of validation experience in regulated industry required.
  • Minimum of two (2) years of software validation experience required.
  • Demonstrated knowledge of cGMPs, FDA regulations, SOP implementation, and validation principles and compliance standards.
  • Completion of GAMP training.
  • Demonstrated excellent interpersonal, written, and verbal communication skills.
  • Demonstrated ability to work independently.
  • Demonstrated experience working with all levels in an organization.

About Octapharma Plasma:

Octapharma Plasma is a leading provider of plasma-derived therapies for patients worldwide. We are committed to making a meaningful difference in the lives of patients who rely on our life-saving medicines.

What We Offer:

  • Formal training
  • Outstanding plans for medical, dental, and vision insurance
  • Health savings account (HSA)
  • Employee assistance program (EAP)
  • Wellness program
  • 401(k) retirement plan
  • Paid time off
  • Company-paid holidays
  • Personal time

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