Specialist, Deviations

3 weeks ago

Mississauga, Canada Resilience Full time

A career at Resilience is more than just a job - it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit
- Position Summary & Responsibilities

The Deviation Specialist (Specialist) will play an important role in the department by writing deviations, participating in Out of Specification analysis investigation, closing batch documentation prior to release and communicating with internal stakeholders/SME and client. In addition, the Specialist will act as a point of contact between the manufacturing group, QA/client QA and regulatory agencies.
- Authors deviations, Investigations, Environmental Monitoring Excursion and CAPA for Manufacturing (USP/DSP/Fill/Finish//Buffer and PST) including but not limited to investigation handling, leading corrective and preventive actions (CAPA) and tracking batch release items to meet company targets.
- Participates and applies Root Cause Analysis (RCA) tools and ensures CAPAs are implemented to eliminate deviation re-occurrence
- Works closely with department manager and QA to support batch release activities while ensuring investigations comply with quality system requirements
- Actively participates in regulatory, client and internal audits by compiling and providing information to department manager
- Ensures Deviations are closed within assigned timelines to meet client demand and company targets
- Participates in data gathering and analysis for Monthly and Quarterly quality matrix as well ad departmental KPI
- Ensure adherence to GDP, GMP, and safe practices at clinical and commercial scales
- Implement process improvement-related changes
- Ensure corrective and preventative action that have been implemented are effective via Effectiveness Checks (EC)
- Provide support in ensuring batch readiness action items are completed before batch start
- Performs all other job-related duties as assigned
- This is a fixed-term contract role for the next 18 months
- Preferred Qualifications
- Diploma with 3+ years or a B.Sc. with relevant industrial experience in pharmaceutical practices
- Demonstrate ability to review manufacturing, engineering, and quality documentation.
- Strong working knowledge GMP requirements
- Experience in top-tier biopharmaceutical environment
- Knowledge of regulatory agencies HC, FDA and others.
- Behavioural
- NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).
- Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.

Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.

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