QA Project Lead
2 months ago
**Location**:
***
- Mississauga, ON**Date Posted**:
***
- 8/9/2023**Job Number**:
***
- JO-2308-1642**Why join Bora?**
- Competitive salary
- A modern and state-of-the-art facility
- An on-site cafeteria with dedicated chefs
- On-site gym, basketball, and tennis courts**THIS IS A FULL TIME CONTRACT POSITION**
**TITLE**: QA Project Lead
- **DEPARTMENT**:Innovation, Development and Transfer Services
- **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 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.
- Education_
- 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
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