Coordinator, Sterile Validation

Job Summary

The Coordinator, Sterile Validation is responsible for all sterile validation activities at the Apotex Richmond Hill site. The incumbent will work cross-functionally with Engineering, Production and Quality in the execution of validation and re-validation of sterilization processes (i.e. thermal validation, VHP validation), air flow visualization studies, and aseptic process simulations (APS).

Job Responsibilities

• Ensure all sterile validation activities are performed in compliance with corporate policies, FDA, HPFBI, EC, and ICH’s guidelines including but not limited to the following:
  • Thermal (Moist / Dry Heat) and Gaseous (VHP / ETO) Validation
  • Irradiation (Gamma / E-Beam) of Primary Packaging Components
  • Container Closure Integrity
  • Sterilizing Filter Validation
  • Airflow Visualization Studies (Smoke Studies)
  • Filter Validation Studies
• Generate and coordinate the execution of all sterile validation protocols.
• Complete summary reports for Sterilization Validation
• Assess impact of proposed changes to validated production equipment / production processes, evaluate and execute requalification and revalidation when there is significant change in either product or its manufacturing process and for ongoing validation maintenance.
• Preparation of Sterilization Process Validation and other reports for regulatory submissions, including, responses to deficiencies, comparability protocols, new submissions and supplements.
• Operate and maintain equipment/instruments.
• Assist in the calibration of equipment/instruments as required.
• Initiate change controls and update SOPs in the area of expertise.
• Communicate with suppliers to obtain required technical information.
• Provide technical guidance and subject matter expertise to sterile operations and investigations.
• Review validation documentation for compliance with cGMP and SOPs.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
• Minimum B.Sc in Biology / Microbiology / Applied Pharmaceutical Sciences, Engineering or related discipline.
• Knowledge, Skills and Abilities
• Proficiency in Written and Verbal English communication.
• Knowledge of Excel, Word, other Microsoft office programs, and validation software packages would be an asset.

• Experience
  • Minimum 3-5 years of experience in a GMP production environment, sterile manufacturing or validation experience is an asset.