Lead Executive - Annual Product Quality Review

Lead Executive - Annual Product Quality Review About Apotex Inc. 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 Responsible for the following aspects of the Annual Product Review program; Compile annual product quality reviews (APQRs) per applicable SOPs. Collect, analyse and summarize product review data correctly and completely in timely manner. monitoring of execution of APQRs as per due dates Liaising with Project Leaders at Apotex Review of summary reports ensuring collected data is accurate and conclusions are appropriate. Accountable to ensure the compiled annual product reviews and supplementary reports are conducted in a timely manner as per established procedures. Responsible to escalate any critical issues arising from the Product Review. Acts as a technical resource and coach for the business units- internal and external stakeholders and affiliates in regard to the Annual Product Review quality system. Develop and mentor the APQR compilers to meet the compliance levels. Timely Co-ordinate with team and GBS QMS team for Departmental Assigned Training in SAP My HR. Job Responsibilities Perform Annual Product Quality Reviews (APQRs) compilation as assigned. This includes the following at minimum, as per SOP: Manufacturing Process Overview Batches Released / Rejected APIs, Excipients Changes Test Method & Specification Manufacturing / Process Validation, Equipment & Utilities Qualification Sterility Validation / Qualification (If applicable) Packaging Component Deviations/Changes Compendial Review Deviations Critical In-Process Attributes Analytical Test Results Recalls & Field Alerts, Returns Retention Samples Review Technical Agreements (as appropriate) Marketing Authorizations Variations & Post Market Commitments (as appropriate) Complaints Stability Conclusion & Product Rating Concerns, Recommendations & Issues for Follow-Up Perform complete & correct transactions of the data as per SOP / WI’s. Summarize & trend analytical data from LIMS or other acceptable systems. Ensure that the complete APQR is submitted for review & accepted by the Reviewer & Project Leader QA Product Review/Manager, QA Product Review. Co-ordinate with Project Leader(s) – QA Product Review / Manager for completion of the projects. Compile the APQRs within required timelines to ensure that there is adequate time for approvals. Responses to Project Leader’s queries for APQR summary reports as required. Assist in preparation, review & revision of Standard Operating Procedures (SOPs) as required. Monitoring of timelines for compilation, review & submission. Review of APQRs – ensuring raw data is complete, correct & reproducible. Identify system improvement opportunities for data gathering, template content/format & process efficiency. Expert knowledge of SAP transactions used to support the Product Review process. Provide technical support, feedback & guidance to team members to ensure the timely completion of APQRs. Acts as liaison between internal groups providing supplementary information & international affiliates. Communicate findings to the Manager / PLs & escalate any critical issues arising from the Product Review. Ensure timely communication of findings to the key business areas. Maintain the tracking system for compilation & review of assigned APQRs. Generate & provide monthly activity reports to the Manager. Create training materials & programs to support the Product Review process. Ensure that the annual product reviews are performed in full compliance with current procedures. Assist in the development & review of procedures as required. Detailed understanding of Apotex & Site SOPs / document & data systems supporting the Product Review process. Co-ordinate with team for assigned training in SAP My HR for execution. Monthly review of Individual Training log of team members. Expert knowledge of International regulatory requirements that apply to Product Reviews. Provide support to Apotex during regulatory/customer audits related to APQRs. Respond to queries related to the Product Review systems. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, & Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics & Compliance Program, Global Quality policies & procedures, Safety & Environment policies, & HR policies. All other relevant duties as assigned. Job Requirements Education B. Pharm/ M. Pharm/ M.Sc Knowledge, Skills and Abilities Identify system improvement opportunities for data gathering, template content/format, process efficiency. Expert knowledge of SAP transactions used to support the Product Review process. Ensure timely communication of findings to the key business areas. Maintain the tracking system for compilation and review of assigned APQRs. Ensure that the annual product reviews are performed in full compliance with current procedures. Expert knowledge of International regulatory requirements that apply to Product Reviews. Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards. Demonstrated cGMP knowledge. Excellent technical writing, communication skills and interpersonal skills. Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards. Experience Minimum 4–8 years in the pharmaceutical industry with an emphasis on Quality Assurance. At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. 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. Experience Level Executive Level