Specialist, Deviations (Fixed Term Contract)

Resilience • Mississauga, ON

22h

About The Position

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.

Requirements

• Demonstrate ability to perform RCA investigations and lead CAPA initiatives.
• Demonstrate ability to review manufacturing, engineering, and quality documentation.
• Strong working knowledge GMP requirements.
• 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.

Nice To Haves

• Diploma with 3+ years or a B.Sc. with relevant industrial experience in pharmaceutical practices.
• Experience in top-tier biopharmaceutical environment
• Knowledge of regulatory agencies HC, FDA and others.

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

Benefits

• annual cash bonus program
• RRSP/DPSP with a generous company match
• competitive healthcare, dentalcare, vision care, life, LTD, and AD&D benefits package
• fertility healthcare and family-forming benefits
• paid vacation
• paid holidays
• pregnancy and parental leave top-up plan
• tuition reimbursement
• employee referral program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level