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Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
For more information visit: www.apotex.com .
Job Summary
This role is responsible for the following aspects of the Annual Product Review program: product review scheduling, monitoring of execution and due dates, liaising with international affiliates, review and approval at the site level and reporting and follow-up activities. Accountable to ensure that compiled annual product reviews and supplementary reports are conducted in a timely/efficient manner and as per Apotex established procedures.
Responsible to set and facilitate meetings to drive closure of follow up items, communicate findings to management and to escalate any critical issues arising from the Product Review. While acting as a technical resource and coach for the business units and internal and external stakeholders and affiliates in regards to the Annual Product Review quality system. Develop, implement and support process improvement initiatives, to ensure that Product Review records are securely stored and easily accessibleand acts as designate to the manager for approval of product reviews, and product review-related change controls and investigations.
Job Responsibilities
- Oversee the Product Review process, including monitoring of internal timelines, execution and due dates and escalation to management of any issues.
- Identify process improvement opportunities for data gathering, template content/format, process efficiency & coordinate with internal and international groups to establish and execute implementation plans for those improvements.
- Provide general support, feedback and guidance to team members, international affiliates and internal groups to ensure accuracy and completeness of Product Reviews.
- Acts as liaison between internal groups providing supplementary information and international affiliates compiling annual product reviews.
- Review and approve final Executive Summary reports based on supporting information provided by international affiliates, for accuracy, consistency and alignment to established standards.
- Provide support in trouble-shooting or investigating product issues.
- Provides impact assessment on changes and or deviations impacting Annual Product Review system.
- Maintain up-to-date overview of site-specific product related issues (current & historical).
- Communicate findings to management and escalate any critical issues arising from the Product Review.
- Ensure timely communication of findings to the key business areas.
- Set up meetings with key business representatives and international affiliates to review findings, establish/assign responsibilities for CAPA development and implementation.
- Oversee the creation of records associated with follow up tasks stemming from product reviews and monitor their status through to closure.
- Represent QA-Product Review at meetings as necessary.
- Create and maintain a Product Review scheduling and tracking system.
- Monitor execution and deadlines of Product Reviews as per defined schedule and escalate any roadblocks and/or deviations from the schedule to the Manager
- Generate and provide monthly activity reports to the Manager.
- Create training materials and programs to support the Product Review process.
- Liaise with international affiliates and internal team members, customers and stakeholders to review and discuss product review findings, feedback, corrections, follow up items and CAPAs and provide QA recommendations regarding actions such as process improvements or blocking of Master Formula. Provide training support related to the Product Review process, both internal and external.
- Ensure that the annual product reviews are performed in full compliance with current Good Manufacturing Practices Good Documentation practices, Standard Operating Procedures all regulatory requirements & established safety standards.
- Assist in the development and approval of SODs.
- Own the QA-Product Review SODs, ensuring they are in line with Quality Policy, are reviewed on a regular basis, and are updated as necessary.
- Liaise with the SOD group to ensure that all other concerned parties have been consulted and have commented prior to SOD update.
- Create/modify SODs as required via the corporate change control process.
- Detailed understanding of all Apotex document and data systems supporting the Product Review process.
- Expert knowledge of Canadian, US, EU and International regulatory requirements that apply to Product Reviews.
- Provide support to QA-Audit during regulatory/customer audits. Respond to queries related to the Product Review systems.
- Support corporate and departmental compliance initiatives.
- Bachelor of Science Degree or equivalent in a related discipline.
- Knowledge, Skills and Abilities
- Good overall understanding of pharmaceutical manufacturing & testing processes.
- Strong team working skills.
- Ability to mentor and coach others.
- Strong data analysis & decision-making skills.
- Ability to manage multiple priorities in a fast-paced and changing environment.
- Detail-oriented & accurate.
- Experience reviewing & approving technical reports.
- Excellent written and verbal English communication skills.
- Good understanding of Canadian and cGMP regulations, and experience with international regulations (e.g. FDA, EU) an asset.
- Strong organizational, time management & interpersonal skills.
- Ability to work independently.
- Experience with Microsoft Office applications.
- SAP, MS Access, LIMS, TrackWise knowledge
- Experience
- Minimum 3-5 years of experience in the pharmaceutical industry, preferably in a QC or QA role.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
The hiring range for this position is $83,958 - $139,930 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge, skills and experience.
We are looking for top talent. If your qualifications differ from those listed above, the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.
The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization, you can excel based on our pay-for-performance philosophy. With comprehensive benefits, a pension plan to help you save for retirement and learning and development opportunities, we provide a comprehensive package for your personal and professional development.
Apotex will use artificial intelligence to screen, select and/or assess your application for this job.
This job posting is for a role that is currently available and vacant at Apotex.
