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Senior Specialist, Equipment and Systems Validation

2 months ago


Montreal, Quebec, Canada Pharmascience Full time

The Equipment and Systems Validation Specialist plays a crucial role in the validation of complex equipment and systems at Pharmascience. As a key team member, they collaborate with other validation team members on various projects, ensuring seamless execution and adherence to standard procedures.

Key Responsibilities

  • Develop and execute validation protocols for installation, operational, and performance qualification and requalification
  • Supervise and manage the execution of protocol tests, ensuring accuracy and efficiency
  • Manage the revision and approval of protocols, maintaining up-to-date documentation
  • Coordinate and manage documentation related to validation activities, including filing, updating, and preparation
  • Participate in the resolution of deviations and deficiencies, ensuring compliance with regulatory requirements
  • Contribute to audits as a validation expert, providing valuable insights and expertise

Required Skills and Abilities

  • Ability to manage multiple projects simultaneously, prioritizing tasks and deadlines
  • Capacity to review and approve technical reports efficiently, ensuring accuracy and quality
  • Effective communication and writing skills, with the ability to write clear and concise technical reports
  • Ability to work under pressure, adapting to changing circumstances and priorities
  • Strong sense of urgency and prioritization, with excellent communication and teamwork skills
  • Proficiency in software tools such as Microsoft Office and Outlook