Job Summary- Responsible for independently ensuring root cause analysis is conducted on investigations for ApotexOral Solid Dose (OSD) in a timely and efficient manner. Ensures established procedures are followed for all investigations and corrective and preventative actions are implemented. Acts as quality technical resource and reviews all investigation reports for completeness and accuracy, and compliance.
- Responsible for initiating, investigating and reporting on customer product quality complaints in compliance with all applicable regulations and guidelines. Responsible for receipt and triage of customer complaints.
Job Responsibilities- Conducts investigations for complex product failures for Production/Packaging deviation and/or Technical and Medical Complaint investigations for all areas in manufacturing/packaging at Signet site following existing procedures. Recognize critical path for investigations leading to timely identification of root cause, corrective & preventative actions. Writes product failure investigation reports for approval by Department Manager or Quality, as required.
- Notify appropriate Team Leaders of validation, raw material, stability & in-process failures and ensure investigations are initiated and completed as per existing procedure. Act as quality technical resource and provide support & guidance to groups within Operations.
- Perform an initial triage for criticality and ensure critical investigations with potential market impact follow the internal escalation procedure.
- Participate in the preparation of Presentation and Incident Response Committee Meeting materials.
- Laise with Apotex affiliates and customers to provide appropriate notification of critical events and coordinate preliminary investigation and escalation activities.
- Interface with customers to obtain required information for investigation and escalation of technical complaints
- Prepares and issues customer complaint acknowledgement letters, sample return instructions, response letters and provides investigation report to customer as per quality agreement.
- Conducts follow-up for receiving of complaint sample and performs cycle count on controlled substance complaint samples in compliance with the procedure.
- Receive, distribute, log and coordinate receipt of all complaint samples
- Independently book and facilitate meetings with multiple Subject Matter Experts (SME's) as required.
- Ensure identification of most probable root cause, corrective action & preventative action for all completed investigations. Review all investigation reports for completeness and accuracy prior to approval by Department Manager or Quality, as required.
- Conduct impact analysis of proposed corrective & preventative actions. Discuss findings with impacted departments (QA, RA, Validation, Production, ect) and prepare recommendations for Department Managers.
- Review on-going progress on all open investigations with Production Investigations team and Area Managers.
- Ensure investigations are issued; tasks are appropriately assigned for completion or corrective and preventative actions and are closed in a timely fashion.
- Project manages the corrective and preventative actions and assists in both implementation and follow-up.
- 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 and posses good critical thinking and problem-solving skills
- 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.
The hiring range for this position is $73,008 - $121,680 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.
