Equipment and Systems Validation Specialist

The Equipment and Systems Validation Specialist participates in the qualification and requalification of complex equipment/systems at Parmascience. As a team member, they will also help other validation team members in their projects. He or she acts as a validation project manager and ensures that all stages of the project are followed in accordance with standard procedures (health and safety, Good Manufacturing Practices, etc.). He or she coordinates activities of all involved parties: professionals, entrepreneurs, consultants, regulatory bodies, as well as acting as a liaison to internal clients.

Responsabilities

• Write validation protocols – installation, operational and performance qualification
• Execute or supervise the execution of the protocol tests
• Manage the revision and approval of protocols
• Manage the documentation related to validation activities (filing, update and preparation)
• Participate in the resolution of deviations and deficiencies
• Participate in change control evaluations and updates for validated systems
• Participates in audits as a validation expert
• Participate in regular meetings with the validation team
• Help/support the documentation team for the writing of SOPs
• Writes technical notes when required
• Works in collaboration with the project engineering team
• Executes periodic requalifications (including but not limited to sterilization and depyrogenation cycles).
  
  

Skills, Knowledge And Abilities

• Minimum 3 years’ experience in qualifying equipment used in manufacturing and/or packaging of various pharmaceutical forms, as well as critical systems (HVAC, purified water, compressed air)
• Capacity to develop all documents required for 21 CFR part 11 compliance, including URS, validation plans, qualification protocols and summary reports
• Knowledgeable in automated and computerized systems qualification (ex. BAS)
• Capacity to manage multiple projects simultaneously
• Capacity to review and approve technical reports efficiently
• Capacity to write technical reports in a neat and concise manner
• Ease in managing pressure and adapting to change
• Possess a good sense of communications and urgency (prioritization)
• Enjoys teamwork and exchanges
• Capabilities in software tools such as Microsoft Office, Outlook.
• Good capacity for problem solving
• Experience with SAP. Trackwise and other electronic document management systems is an asset.
• Dynamic and autonomus
• Fluent in French and English (spoken and written) The person will be required to work with regulatory authorities located outside the Province as well as Suppliers and write documentation.