Catalent Pharma Solutions Quality Compliance Coordinator in Strathroy, Canada

Job Description

The Quality Compliance Coordinator reports to Compliance Manager

Strathroy, Ontario is one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health industries. We have a broad range of integrated formulation, manufacturing, analytical and packaging services to offer full service turnkey solutions.

If you would like to be part of a global drug development and delivery leader, then this role might be for you!

The Quality Compliance Coordinator applies in-depth knowledge of products, processes, testing methods and statistical process control to ensure the safety and efficacy of the drugs we make for our patients. The Quality Compliance Coordinator reviews yield results, methods, specifications and Nonconformity Reports (NCRs) through Annual Product Reviews (APRs) in addition to coordinating/investigating customer complaints.

The Role

  • Provides services leading to, and inclusive of, preparation of Annual Product Reviews and Trend Reports for all pharmaceutical products marketed, in compliance with SOPs and cGMP regulations

  • Acts as the primary point of contact for customer complaint investigation; leads and performs related responsibilities as required

  • Acts as the administrator of the change control system, initiating, routing and tracking change controls

  • Track any commercial Annual Product Review NCR’s, and corrective actions, updating the NCR system as required, and ensuring that timelines are adhered to

  • Achieves Required Results in productivity, quality and services as defined through key performance indicators for the department

The Candidate

  • University degree, preferably a Bachelor’s Degree in Science, Engineering, Mathematics, Statistics or related field

  • Preferably 3-5 years of experience in process/product improvements or in the preparation of pharmaceutical reports including annual product reviews

  • Preferably experience working in a manufacturing, pharmaceutical and/or GMP facility an asset

  • Ability to use statistical methods and tools to identify and diagnose quality control trends

  • Flexibility to shift priorities quickly and effectively; manages simultaneous requirements

Position Benefits

  • Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)

  • Group Retirement Savings – Defined Registered Pension Plan (RPP) with employer contributions

  • Paid Time Off Programs incl. vacation, banked time & personal time

  • Employee Reward & Recognition programs

  • Opportunities for professional and personal development & growth incl. tuition reimbursement

We will identify candidates based on the following Catalent Competencies:

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

About Catalent

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities, or contact us at

+1 877 503 9493.

Catalent is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin or disability. Accommodations are available for applicants with disabilities throughout the recruitment process. If you are selected for an interview and require accommodation for interviews or other meetings, please advise your Human Resources point of contact or email accessibility@catalent.com.

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.