Overview
Specialist, Deviations Jobs in Mississauga, ON at Resilience
Full job description
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
www.resilience.com
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
Demonstrate ability to apply the following behavioural competencies on the job: Teamwork: Working effectively and productively with others Independence: Ability to work with minimal supervision Flexibility: Agility in adapting to change Written Communication: Writing clearly, succinctly and in a manner understood by the target audience. Problem Solving: Anticipating, analyzing, diagnosing and resolving problems Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective Interpersonal Skills: Effectively communicating, building rapport and relating well to all personality types Diligence: Attention to detail. This job profile provides an overview of the minimum requirements of the job and does not include all of the duties inherent, included or associated with the job or with the…
Title: Specialist, Deviations
Company: Resilience
Location: Mississauga, ON
Category:
