Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents , ideas and passion are essential to our mission; to develop, manufacture and supply
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents , ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
Annual Product Quality Review & Complaint Coordinator- Contract
The Annual Product Quality Review & Complaint Coordinator role reports to the 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.
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. Reviews yield results, methods, specifications and deviations through Annual Product Reviews (APRs) in addition to coordinating/investigating customer complaints.
Be a part of a global drug development and delivery leader, and help others live better healthier lives!
This is a Fixed Term Contract Position
The Role (daily responsibilities)
- 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
- Track any commercial Annual Product Review NCR’s, and corrective actions, updating the NCR system as required, and ensuring that timelines are adhered to.
- Assists in the collection and pre-review of requested documents in advance and during site inspections.
- Assists in the collection and pre-review of customer audit responses.
The Candidate (requirements)
- 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
- General knowledge of pharmaceutical manufacturing processes
- Ability to influence stakeholders, build trust and respect within the overall organization.
- Flexibility to shift priorities quickly and effectively; manages simultaneous requirements.
- Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance);
- Group Retirement Savings – 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.
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 www.catalent.com/careers to explore career opportunities.
C atalent 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, sexual orientation or gender identity. 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 [email protected] . 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.