Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

How will you make an impact?

Support the oversight of Quality Systems to drive the performance of Investigations, CAPAs, and Change Controls. Perform as Global TrackWise Administrator, and Power BI Subject Matter Expert for the Whitby Site. Perform routine reporting of key quality systems metrics in support of daily, weekly and monthly forums inclusive of authoring Quarterly Trend Reports. Maintain Quality Systems procedures in compliance with corporate and regulatory requirements. Support corporate and client audits, in addition to client regulatory inspections.

What will you do?

Essential Functions:

• Perform as Global TrackWise (GTW) Administrator for the Whitby Site
• Perform as Power BI Subject Matter Expert
• Initiate, lead, and author investigation reports in TrackWise for Quality Systems deviations to identify root cause and propose appropriate CAPAs to prevent recurrence
• Gap assess and author Quality Systems related SOPs and WIs to ensure compliance to corporate and regulatory requirements.
• Support continuous improvement of Quality Systems through Practical Process Improvement (PPI) concepts.
• Monitor performance of Investigations / Deviations, CAPAs, and Change Controls through identification, monitoring, trending, and reporting of key performance indicators.
• Ensure adoption of standard and consistent approach to Quality Systems across the site, and ensure integrity of system in compliance with Regulatory, Corporate, and Site requirements.
• Support the creation and delivery of training in support of implementing Quality Systems related enhancements to ensure adherence to requirements in support of compliance and improved performance.
• Prepare the agenda and content for Quality Systems daily huddles and weekly review boards in support of driving the performance of Quality Systems, facilitate when required.
• Author Quarterly Trend Reports to ensure timely issuance and proactive identification of trends and have action plans in place to address them.
• Support Regulatory Inspections, Corporate Audits, and Client Audits specific to the functions within the Quality Systems team.
• Support special projects as assigned.
• Maintains a safe working environment and reports potential hazards.

How will you make an impact?

Education:

Bachelor of Science (B.Sc.) in Chemistry, Pharmacy or a science related to pharmaceutical analysis

Experience:

Minimum 5 years experience in the pharmaceutical industry.

Minimum 2 years experience in Quality within the pharmaceutical industry.

Previous experience with Quality Systems an asset (i.e. TrackWise).

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills and Abilities:

Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language. Strong ideas, decision making abilities, trouble shooting and thinking-out-of-the-box skills. Excellent organizational, verbal and written communication skills. Familiarity with GMPs. Works well with limited supervision. Excellent organizational, interpersonal, oral and written communication skills. Experience in Microsoft Word, Excel, Access. Experience with EDMS, SuccessFactors LMS is an asset.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Job Category

Quality

Thermo Fisher Scientific

is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.