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Quality Assurance Manager

2 months ago

Mississauga, Ontario, Canada Bora Pharmaceuticals Full time
{"title": "Quality Assurance Manager", "content": "Job Summary

Bora Pharmaceuticals is a global leader in the development and manufacturing of branded, generic, and over-the-counter (OTC) healthcare and pharmaceutical products. Our mission is to ensure the mutual success of our partners by maintaining high standards of quality, reliability, and efficiency.

Key Responsibilities
  • Ensure the quality of ointment, creams, and liquid (OCL) products and/or Solid Dose products manufactured and packaged at Bora Mississauga.
  • Oversee the release of OCL and Solid Dose products.
  • Responsible for investigation of deviations pertaining to manufacturing, packaging, and testing of OCL and Solid Dose products, identifying true root cause of incidents and assigning corrective and preventative actions.
  • Approve complaint investigations for OCL and Solid Dose products, identifying true root cause of incidents and assigning corrective and preventative actions.
  • Approve periodic product reviews for OCL and Solid Dose products.
  • Oversee validation program for the site.
  • Evaluate and approve planned changes pertaining to OCL and Solid Dose raw materials, products, processes, and equipment.
  • Host pre-approval inspections for OCL and Solid Dose products and may co-host other inspections and audits.
  • Respond to queries from regulatory authorities, third-party auditors, and internal auditors.
  • Responsible for providing Bora quality oversight for customer recalls of products manufactured and packaged by Bora Mississauga.
  • Act as a Quality point of contact with Customers.
  • Lead, coach, and mentor team members.
  • Lead staff to optimize operational effectiveness.
  • Manage performance process and career development of staff.
Requirements
  • Experience in operational quality assurance or related role with similar responsibilities.
  • Demonstrated effective management of issues.
  • Experience with external communications with customers.
  • Sound knowledge of regulatory framework and ability to make informed decisions and release product to market as per GMPs.
  • Demonstrated ability to lead projects or change initiatives.
  • Demonstrated ability to influence and lead others as well as the ability to make sound quality decisions.
  • Strong interpersonal and communication skills.
Education

Bachelor's degree in Science or related field or equivalent on-the-job experience through years of service.

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