Manager, QA Operational Quality

Job title:

Manager, QA Operational Quality

Company

Hudson RPO

Job description

General Description:
Quality Manager is responsible for management of the operational quality activities to ensure product quality and compliance is maintained and to manage staff accountable for operational quality deliverablesKey Responsibilities:

• Ensure the quality of ointment, creams and liquid (OCL) products and/or Solid Dose products
• manufactured and packaged at Bora Mississauga
• Oversee 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. Also identifies and investigates trends
• Oversees shift oversight activities for all shifts on site
• Approves complaint investigations for OCL and Solid Dose products identifying true root cause of incidents and assigning corrective and preventative actions
• Approves periodic product reviews for OCL and Solid Dose products
• Overseas validation program for the site
• Evaluates and approves planned changes pertaining to OCL and Solid Dose raw materials products processes and equipment
• Hosts pre-approval inspections for OCL and Solid Dose products and may co-host other inspections and audits. Responds to queries from regulatory authorities, third party auditors and internal auditors
• Responsible for providing Bora quality oversight for customer recalls of products manufactured packaged by Bora Mississauga
• Act as a Quality point of contact with Customer
• Leads, coaches and mentors team
• Leads staff to optimize operational effectiveness
• Manages performance process and career development of staff

Experience and Skills:

• 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 (Required):

• Bachelors 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 at [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

Expected salary

Location

Mississauga, ON

Job date

Fri, 02 Aug 2024 22:42:43 GMT

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