Operational Quality Manager - Mississauga, Canada - Bora Pharmaceutical Services

Bora Pharmaceutical Services
Bora Pharmaceutical Services
Verified Company
Mississauga, Canada

3 weeks ago

Sophia Lee

Posted by:

Sophia Lee

beBee Recruiter
Description

Location:

***- Mississauga, ON
Date Posted:***- 5/30/2023
Job Number:***- JO
Department: Quality Assurance

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Position reporting to: Director, Quality
General Description:

Management of the operational quality activities to ensure product quality and compliance is maintained and to manage staff accountable for operational quality deliverables.

Liaise with clients as required to ensure issues are shared and resolved appropriately.


Responsibilities:


  • Responsible for ensuring the quality of products manufactured, packaged, and tested at Mississauga; communicating with clients as required
  • Point contact with clients; managing expectations aligned with Supply and Quality agreements
  • Oversees review and release of products
  • Responsible for investigation of all site deviations identifying true root cause of incidents and assigning corrective and preventative actions. Also identifies and investigates trends; Communicating with clients as required
  • Oversees Quality shift oversight activities for all shifts on site.
  • Approves investigations of complaint samples for all products, identifying true root cause of incidents and assigning corrective and preventative actions
  • Approves periodic product reviews
  • Provide Quality oversite and approves process, equipment, and facility validation documents
  • Evaluates and approves planned changes pertaining to raw materials, products, processes, and equipment
  • Hosts inspections/audits for products and general GMP
  • Responds to queries from Regulatory authorities, third party auditors and internal auditors.
  • Responsible for site recall activities for products for products manufactured/packaged by Bora Mississauga site
  • Leads, coaches, and mentors' team; managing the performance and career development processes for staff
  • Leads staff to optimize operational effectiveness

Qualifications:


  • Experience in Operational Quality Assurance or related role with similar responsibilities, demonstrated effective issues management, experience with external communications with customers; Minimum 10 years in Pharma industry
  • Demonstrated ability to lead projects or change initiatives, to influence and lead others as well as demonstrated ability to make sound quality decisions.
  • Demonstrated ability to simplify/lean Q processes.
  • Strong interpersonal and communication skills.

Education:


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

Working conditions:


  • Office based with requirement to enter production areas. Need to spend many hours per day on a computer.
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