Quality Assurance Associate

1 week ago

Scarborough, Canada Stefanini, Inc Full time

**Stefanini Group is hiring**

**Stefanini is looking for**
**Quality Assurance Associate for Toronto, ON**
**Location**

**For quick Apply, please reach out to Shubham Singh - call**:
***

**Work shift (days/times) - **M-F (40 hours)

**Work Location - **Toronto, ON

**Shift**:1st Shift.

***

**Summary**:

- The Quality Assurance Associate will provide support to operations by providing oversight to activities associated with the manufacturing and packaging of bulk and finished products by third party suppliers to ensure compliance with GMPs. Review and approve supplier documentation related to product release, validation, deviation, change controls, etc. Perform release of third party products to market. Perform impact assessment with respect to the critical GMP issues.
- The QA Associate will Provide oversight of activities associated with the manufacture & packaging of bulk & finished products by 3rd party suppliers to ensure compliance with GMPs.

**Essential Duties and Responsibilities**:

- Review & approve GMP documentation associated with 3rd party supplied bulk & finished products including release documentation, deviations, validations, change controls, etc.
- Liaise with 3rd party suppliers to ensure compliance with GMPs, adherence to Quality agreements & to resolve quality issues
- Ensure compliant, on-time launches of 3rd party product in coordination with internal & external groups
- Investigate Product Complaints and ensure the timely closure of the records in Harmony Trackwise
- Perform comprehensive and detailed investigations for quality deviations (DR's) related to 3rd party products in a timely manner
- Provide metrics to Client Global / Track KPIs for overdue deviations, CAPAs, batch release cycle time, etc.
- Generate / trend monthly and quarterly reports;
- Follow up and facilitate the completion of change controls, DRs, CAPAs and CAPAERs in a timely manner
- Request stability data from the suppliers and perform stability review for all the third party products;
- Draft / revise, negotiate and execute Quality Agreements with manufacturing sites, contract packagers, contract laboratories, etc.
- Perform impact assessment for third party products towards Critical Incident Notification / Alerts
- Perform Executed Batch Record Review for third party products
- Review internal procedures and Corporate Standards, perform gap assessment and update SOPs accordingly
- Perform retain sampling activities: conduct the receipt of retain samples, updating of Oracle / storage of retain samples and destruction of expired retain samples as per procedures
- Support other Compliance functions and projects as required
- Lead / Manage special projects that require collaboration with cross-functional teams and Client Global Affiliates
- Hazard Recognition and Investigation Skills: Identify, prevent, and proactively correct workplace hazards and conditions. Perform incident/accident investigations, root cause analysis, and establish appropriate corrective actions.
- Role Modeling: Role modelling of EHS practices to prevent the release of materials/energy, reduce EHS impacts, and ensure adherence to EHS regulatory requirements and procedures

**Qualifications**:

- University Degree in Science or related discipline from a recognized Canadian University (or non-Canadian institution evaluated as Canadian equivalent)
- Must have a minimum of 1 (one) year relevant experience in Quality Control, Quality Assurance.
- 3 (three) + years relevant experience in Quality Control, Quality Assurance or a proven track record within pharmaceuticals is preferred.
- Knowledge of USP, BP, EP compendia methods as well as ability to read and interpret house methods.

**Must have**:

- Batch record review.
- Review & approve GMP documentation with 3rd party supplied bulk & finished products including release documentation, deviations, validations, change controls, etc.
- Global communications experience.
- Great verbal & written communication.
- University degree in Science or related discipline from a recognized Canadian University ( or non-Canadian institution evaluated as Canadian equivalent).

**Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.

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