Job Description

Position Summary

The Annual Product Quality Review & Complaint Coordinator applies in-depth knowledge of products, processes, testing methods and Statistical Process control to ensure safety and efficacy of drugs. The Annual Quality Product Review Coordinator reviews yield results, methods, specifications and deviations through Annual Product Reviews (APRs) in addition to coordinating/investigating customer complaints.

This position is located in Windsor, Ontario, 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.

Shift: Onsite - Regular working hours: 8:00 AM \xe2\x80\x93 4:30 PM or 8:30 AM \xe2\x80\x93 5:00 PM with a 30-minute unpaid lunch.

The Role

Provides services leading to and inclusive of, preparation of Annual Product Reviews 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.

Provides services leading to and inclusive of, preparation of Trend Reports for the organization, in compliance with SOPs and cGMP regulations.

Creates product and raw material analytical report and certificate of analysis templates.

Supports in the creation of items and bills of materials in Fourth Shift for all items, and in Gel Program as appropriate. Supports the revisions to content as required, based on submitted approved change requests. Supports the site administrator of the change control system in initiating and tracking change controls.

Tracks any commercial Annual Product Review investigations, and corrective actions, updating the system as required, and ensuring that timelines are adhered to. Assists in the administration of TrackWise Quality Management System.

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

Must be able to work extended hours, weekends as needed, especially when problems occur or when deadlines must be met.

Performs other duties as required.

The Candidate

University degree, preferably a Bachelor\xe2\x80\x99s 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

Ability to influence stakeholders, build trust and respect within the overall organization.

While performing the responsibilities of the job, these work environment characteristics are representative of the environment the employee will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.

Why You Should Join Catalent

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

Group Retirement Savings \xe2\x80\x93Registered Pension Plan (RPP) with employer contributions.

Paid Time Off Programs including vacation, banked time & personal time.

Employee Reward & Recognition programs.

Opportunities for professional and personal development & growth including tuition reimbursement.

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 is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone\xe2\x80\x99s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

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Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.

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, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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