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Quality Assurance Manager
2 months ago
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.
We believe that our own success is intertwined with that of our partners, driving us to consistently deliver exceptional results.
Our comprehensive pharmaceutical supply chain covers research and development, sales, and distribution.
We focus on producing and marketing generic, brand, and OTC drugs to clients worldwide, with a dedication to meeting diverse healthcare needs.
Job Summary:We are seeking a talented and experienced professional to join our team as a Manager, QA Operational Quality.
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.
- Identify and investigate trends.
- Oversee shift oversight activities for all shifts on site.
- 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.
- 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.
Bachelor's degree in Science or related field or equivalent on-the-job experience through years of service.
Preferred: 5-10 years in the pharma industry.
Bora is an equal opportunity employer committed to diversity and inclusion.
We welcome applications from all qualified individuals to apply to our career opportunities.
Bora is committed to accommodating persons with disabilities.
If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us.