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Validation Specialist

May 23 2017
Industries Pharmaceutical, Biotechnology
Categories Quality assurance and control - Validation
Montreal, QC

http://www.greencrossbt.com/careers/

Position Title: Validation Specialist
Reports to: Technical Services Lead

Position Summary

The Validation Specialist is to support validation activities during the implementation, execution and maintenance of all equipment qualification, manufacturing process validation, cleaning validation and computerized systems validation programs at GCBT.   

Key Duties and Responsibilities

  • In conjunction with the Process Lead, review and approve vendor's equipment qualification, manufacturing process validation, supporting the construction, commissioning, qualification and operation of a blood fractionation facility
  • Ensures that validation requirements are addressed within all quality (I.e.: Change Control) and operations programs
  • Review and approve deviation and investigation reports related to quality issues as well as assess customer complaints and ensure timely corrective action is undertaken
  • Ensure that all validation activities comply with cGMPs and GCBT internal procedure
  • Support product development and regulatory approval programs as required
  • Review and approve risk assessment for all equipment procurements as per approved Risk Assessment procedure
  • Ensure cleaning, process, filter, viral clearance, visual inspection and sterilization validation program meets cGMP and VMP
  • Ensure equipment numbering, calibration program and preventive maintenance programs meet cGMP and VMP
  • Ensure that the technology transfer process for all new product introduction to the facility meets GCBT and regulatory requirements
  • Write, review and approve GMP compliant standard operating procedures (SOPs) in regards to validation and process related activities
  • Perform additional duties as assigned

Qualifications

  • University degree in Engineering or Science
  • Minimum 5 years' experience in validation and sterile manufacturing process projects
  • Must have excellent organizational, verbal and written communication skills and be able to efficiently communicate with cross-functional teams and management on recommended course of action, with minimal assistance
  • Experience in multidisciplinary teams as well as teams with members from international locations
  • Strong ability to effectively discuss and resolve complex technical and operational issues with management
  • Must have proficient computer skills
  • Competency in both French and English

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