Quality Assurance Project Lead

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. At Bora, 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, branded, and OTC drugs to clients worldwide, with a dedication to meeting diverse healthcare needs.

Why join Bora?

• Competitive salary
• A modern and state-of-the-art facility
• An on-site cafeteria with dedicated chefs
• On-site gym and basketball court

Click here for a video tour of our Mississauga facility: https://lnkd.in/evhPktDN

POSITION DESCRIPTION

Job Title: QA Project Lead

Department: Quality

Position Reporting To: QA Manager-Projects

Employment Type: Fulltime Permanent

General Description

Provides Quality leadership and makes relevant decisions to ensure successful completion of significant projects including new client boarding and manufacturing of development, clinical, registration and validation batches.

Responsibilities:

• Provide Quality leadership to support introduction of new clients and products from development to commercialization; creating and streamlining systems/processes as required.
• Lead Quality discussions, making appropriate decisions, to support the successful on-boarding of new clients, products, or processes.
• Represent Quality at project meetings, acting as a liaison to other areas of Quality e.g., QC.
• Support review of batch records (master or executed) and associated documentation, disposition of batches, deviation investigations for non-commercial production.
• Support the quality aspect of planned changes raised to support non-commercial projects, ensuring compliance to procedures and regulations.
• Provide final quality approval on documentation generated to support projects. This will include technical reports, validation/verification reports, analytical methods, specifications, risk assessments etc.
• Participate actively in Client and/or Regulatory inspections.
• Participate in the creation/coordination of documentation/declarations to support Client registration activities.
• Ensure smooth transition of activities to routine business.

Qualifications

Experience and Skills:

• Minimum 5 years' experience Quality Operations in the pharmaceutical industry. Similar experience in an equivalent industry would be considered. Manufacturing experience is an asset.
• Demonstrated understanding of the regulatory framework and current industry quality standards from development to commercialization.
• Experience in interpreting regulations as it relates to all different stages of drug manufacturing.
• Demonstrated ability to develop and learn processes.
• The ability to influence, problem solve and support other members of your team.
• Demonstrated ability to make sound quality risk-based decisions in a fast-paced environment.
• Computer literate with excellent writing skills and communication skills.
• Experience in new product introduction (NPI), early development and clinical trial submissions will be a strong asset.
• Strong communication skills are a must as this role requires interfacing with clients.

Education

Required:

• Bachelor’s degree in science or related field and/or on the job experience in pharmaceuticals Area(s) of Specialization

Working Conditions

• Must be able to work with a computer for several hours per day.

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.