QA Project Lead - Mississauga, Canada - Bora Pharmaceutical Services

Bora Pharmaceutical Services

Verified Company

Mississauga, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Location:

***- Mississauga, ON
Date Posted:***- 8/9/2023
Job Number:***- JO
Why join Bora?

Competitive salary
A modern and stateoftheart facility
An onsite cafeteria with dedicated chefs
Onsite gym, basketball, and tennis courts
THIS IS A FULL TIME CONTRACT POSITION

TITLE:
QA Project Lead

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DEPARTMENT:Innovation, Development and Transfer Services
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POSITION REPORTING TO: QA Manager

Projects
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 onboarding 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 noncommercial production.
Support the quality aspect of planned changes raised to support noncommercial 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 riskbased decisions in a fastpaced environment.
Computer literate with excellent writing skills and communication skills.
Education_
Bachelor's degree in science or related field and/or on the job experience in pharmaceuticals Area(s) of Specialization

WORKING CONDITIONS