Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

How will you make an impact:
Manage a portfolio of Clients and update quality plans/quality performance for clients, supports product transfers from Pharmaceutical Development Services (PDS) and external to Commercial operations.
Provide on floor Quality (Q) support, attend RAPIDS and performs deviation investigations. Participate in
Failure Mode and Effect Analysis (FMEAs) and process improvements determined from trending data.

What will you do:
Manage multiple small-medium projects and/or improvement initiatives
Lead risk analyses
Assure continuous Quality improvement in plant related to trends from Quality systems
Lead Quality initiatives, and provide Q support throughout the facility, quality assessments on process
improvement activities such as Mini Ts, Kaizens
Work with management to resolve project issues and resource constraints within the team.
Support decision making on projects and future directions by trending deviations in Global Track Wise (GTW)
Maintain positive team member interactions and manages conflict with assistance from Quality Manager
Plan, monitor, and ensure completion of Metrics, CAPAs and quality approvals
Support Quality investigations related to Site, Incoming material, Complaints and products
Facilitate content of Quality Huddles, represent Quality at RAPIDs, and material under investigation
Prepare Quality Agreements for approval
Assure GTW compliance
Manage client satisfaction by updating quality plans and coordinates customer requests
Manage a portfolio of Clients of moderate to high complexity and will be the key contact
Monitor Voice of the Client (VOC) and builds improvement plans
Prepare quality presentations for Client meetings and present
Support PAI or Client audits as necessary
Support the implementation of Quality Agreements
Maintain a safe working environment and report potential hazards.
Perform alternating or rotating shift work (as required)
How will you get here?
Education:
Bachelor of Science (B.Sc.) in Chemistry, Pharmacy, Microbiology, or Engineering

Experience:
Minimum 5 years of previous related experience in pharmaceutical/food industry, preferably in a QA function
Pharmaceutical development experience is an asset
Project management experience or client management experience an asset
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Strong self-motived individual. Ability to work independently, and within a team environment. Well organized and detail oriented with the ability to meet deadlines. Ability to prioritize multiple tasks

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.