Quality Validation Coordinator

6 days ago

Richmond Hill, Ontario, Canada APOTEX Full time
About the Role

We are seeking a highly skilled Quality Validation Coordinator to join our team at Apotex, a leading global health company. As a Quality Validation Coordinator, you will play a critical role in ensuring the quality and safety of our products.

Key Responsibilities
  • Performance Qualification: Author, coordinate, and execute performance qualification protocols for all applicable production equipment.
  • Sterilization Validation: Author, coordinate, and execute sterilization validation protocols for all applicable production equipment and process simulations (media fills).
  • Cleaning Validation: Author and summarize cleaning validation risk assessment reports, and author and summarize cleaning validation protocols in accordance with FDA, HPFBI, EC, and ICH's guidelines.
  • Regulatory Submissions: Prepare sterilization process validation and other reports for regulatory submissions, including responses to deficiencies, comparability protocols, new submissions, and supplements.
  • Equipment Maintenance: Operate and maintain equipment/instruments designated to Quality Validation & Engineering RH.
  • Calibration: Assist in calibration and calibrate equipment/instruments as required.
  • Documentation: Write SOPs or Change Control Forms in the area of expertise.
  • Requalification and Revalidation: Evaluate and execute requalification and revalidation when there is significant change in either product or its manufacturing process and for ongoing validation maintenance.
  • Technical Support: Communicate with suppliers to obtain required technical information and provide technical support in the area of expertise as required by other departments.
  • Peer Review: Peer review of validation documentation for errors/omissions, comprehension, and compliance with cGMP and SOPs.
  • Compliance: 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.
Requirements
  • Education: A Bachelor of Science degree in a related field or an engineering degree.
  • Knowledge and Skills: Proficiency in written and verbal English communication, knowledge of Excel, Word, other Microsoft office programs, and validation software packages.
  • Experience: Minimum of three to five years in validation, with experience in sterilization validation, cleaning validation, equipment qualification, and regulatory submission (sterilization).

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