Job Description

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.)

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.