Diploma with 3+ years or a B.Sc. with relevant industrial experience in pharmaceutical practices.
Demonstrate ability to perform RCA investigations and lead CAPA initiatives.
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, delegates tasks and works with all members of the team to ensure timelines are met
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, analysing, diagnosing and assisting the team to resolve 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.
Benefits
Health insuranceDental insuranceVision insurancePaid time offPerformance bonusParental leave
Additional Information
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
JOB SUMMARY:
The Deviations Specialist will play an important role in the department by unblocking, investigating and authoring deviation reports. Deviation Specialists also participate in Out of Specification analysis investigations, 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 and regulatory agencies.
MAJOR RESPONSIBILITIES:
Responsible for identifying recurring Deviations/Non-conformances and ensure appropriate actions are taken
Capture immediate actions and initial impact in deviation records to help ensure issues are remediated prior to proceeding with manufacturing
Effectively and efficiently write deviation investigations. Develop an investigation strategy, perform Root Cause Analysis by selecting appropriate analytical tools, collect and analyse data to determine root cause
Prepare operations investigations to support other functional areas as required, performed the deviation review process and ensure deviation investigations close according to targeted timelines
Accountable for working on problems associated with a wide variety of quality issues that range from errors in production, incomplete batch records, component reconciliation, poor documentation practices etc.
In collaboration with platform management and other stakeholders, develop appropriate CAPAs with a clearly defined scope to address the root cause
High level of knowledge of cGMPs in pharmaceuticals/biological manufacturing environment
Work with internal stakeholders, SMEs, client to review/finalize investigations prior to closure
Ensure deviations are closed in a timely manner
Performs all other job-related duties as assigned
18 Month Fixed Term Contract Position
Resilience · - On - Mississauga - Meadowpine Blvd, Canada