Quality Management System Specialist

5 days ago

Strathroy, Canada Catalent Full time

Quality Management System Specialist

Position Summary

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. This is an exciting opportunity to play a pivotal role in developing the strategy for our new pharmaceutical site and shape the future of our operations in North America.

Reporting to the Quality Assurance Supervisor, the Quality Management System (QMS) Specialist will maintain the company’s various quality management systems to ensure GMP compliance. The QMS Specialist will be required to organize and conduct assessments regarding Suppliers, product complaints, internal compliance, change control, etc.

Regular working hours: 8:00 AM – 4:30 PM or 8:30 AM – 5:00 PM with a 30-minute unpaid lunch

The Role

Participate in various quality system areas, including customer regulatory inquiries, change control, document control, and metrics provision.

Maintain the facility’s supplier assessment program, reviewing supplier audit reports, complaints, and material reviews.

Deliver the internal audit schedule, participate in self-inspection and review internal audit reports.

Support in the preparation of Quality Systems trend reports. Provide recommendations where required as a result of observed trends and lead/support continuous improvement initiatives.

Review, approve (if applicable) and close QMS systems records.

Participates in investigations and corrective action identification/ implementation for Deviations and Complaint documentation. Ensures on-time closure of such items.

Generates Annual Product Quality Reports (APQR) for Management review/ approval.

Develop the Quality Management System towards optimum efficiency by leading small teams thought the implementation of new systems and ways of working.

Perform other duties as required.

The Candidate

Diploma / bachelor's degree preferable in a related field.

Minimum 3 years of experience in Quality, Operations, or related field.

Experience working in a complex regulated manufacturing environment.

Previous experience in Quality Management System, preferably within the pharmaceutical industry, is highly desirable.

Experience of preparation, involvement relating to FDA and HPFBI inspections is desirable.

Knowledge of GMP compliance and regulatory requirements with a strong understanding of quality systems.

Experience in generating controlled documents.

Effective attention to detail and a high degree of accuracy.

Strong organizational and time management skills to prioritize tasks, allocate resources effectively, and meet schedules.

Demonstrate applicable ethics and due diligence.

Excellent communication (written and verbal), and interpersonal skills.

Strong computer skills including Microsoft Office Suite (Outlook, Excel, PowerPoint, Word) and familiarity with quality management systems and related software is advantageous.

Ability to respond quickly to a changing regulatory environment. 

While performing the responsibilities of the job, the employee is required to talk and hear.

The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard. Use of manual dexterity is required.

The employee is occasionally required to stand, walk, reach with arms and hands, bend, or twist, and to stoop, kneel, crouch or crawl.

Vision abilities required by this job include close vision.

Why You Should Join Catalent

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

Group Retirement Savings –Registered 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’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit to explore career opportunities.

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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