Job SummaryResponsible for ensuring all investigations within the Manufacturing and Production departments at Richmond Hill site are completed in a timely and efficient manner. Ensures established procedures are followed for all investigations and corrective and preventative actions are implemented.
Job Responsibilities- Responsible to ensure all manufacturing investigations are investigated and documented in a manner which ensures compliance with site procedures and all applicable GMP's.
- Recognize critical path for investigations leading to timely identification of root cause, corrective & preventative actions.
- Facilitate meetings with multiple Subject Matter Experts (SME's) as required.
- Perform throrough impact analysis in collaboration with all SMEs including Vendors.
- Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations.
- Regularly review on-going progress on all open investigations with Production Investigations team, QA approver team and Production Management team to ensure all timelines are attainable.
- Escalate any roadblock/issues which may pose the risk for meeting the investigation timelines.
- Prepare clear, accurate and concise investigation reports and review the reports for completeness and accuracy prior to approval by Department Manager.
- Lead, oversee, or participate in cross functional projects associated with manufacturing deviation reduction initiatives.
- Assist Production Supervisors/Team Leaders in ensuring investigations are initiated and relevant information pertaining to the deviations are gathered in a timely manner. Act as technical resource and provide support & guidance to groups within Operations.
- Work as members of a team to achieve all outcomes;
- Operate in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
- Perform all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.
Job Requirements- Education
- Post Secondary degree in Engineering, Sciences or a related technical field preferred or equivalent combination of College diploma and experience in a manufacturing environment
- Knowledge, Skills and Abilities
- Fluency in project management & Root Cause Corrective Action (RCCA) tools
- Superior organizational, interpersonal communication skills
- Ability to manage time effectively
- Ability to work independently and manage multiple priorities in a fast-paced and changing environment
- Strong command of the English language, both written and verbal
- Knowledge of Good Manufacturing Practices (GMP)
- Proficiency with Microsoft Word, Excel, and SAP.
- Experience
- 5-7 years' experience in a pharmaceutical or manufacturing industry, preferably in a Manufacturing, Engineering or QA/QC role.
Compensation DataCompensation Data- The hiring range for this position is $ 72,284.85 - 101,198.79 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.
