Coordinator, Sterile Validation (Contract Role)

Apotex•Richmond Hill, ON

7d•CA$63,482 - CA$105,804•Onsite

About The Position

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).

Requirements

Minimum B.Sc in Biology / Microbiology / Applied Pharmaceutical Sciences, Engineering or related discipline.
Proficiency in Written and Verbal English communication.
Minimum 3-5 years of experience in a GMP production environment, sterile manufacturing or validation experience is an asset.

Nice To Haves

Knowledge of Excel, Word, other Microsoft office programs, and validation software packages would be an asset.

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.