Coordinator, Sterile Validation (Contract Role)

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.