Location: 1755 Steeles Ave West Toronto, ON,
Remote Possible?: No
Duration: 6 months
Start Date: 2021-10-18
Scheduled End: 2022-04-29
JOB TITLE: Lead Investigator-Complaints
JOB PROFILE: 1-2
Industrial Affairs, Site Quality Operations (Quality Systems)
LOCATION: Toronto, Ontario, Canada
REPORTING TO (Titles of managers):
Solid Line Manager: Complaints Manager
2nd Level Manager: Deputy Director, Product Surveillance
Dotted Line Manager: N/A REPORTING TO THIS POSITION
(Titles of direct reports): N/A
SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES
(Briefly describe in two to three sentences the major/overall purpose of the job/ why it exists and what are the major expected results.)
Combining a strong understanding of biological manufacturing processes, cGMPs (Current Good Manufacturing Practices), root cause analysis and technical writing skills with the responsibility for managing complaint investigations, manufacturing investigations (MI) related to adverse events, developing and implementing remediation activities and supporting the associated improvements in manufacturing areas as an outcome of the investigations performed.
An ability to execute and manage robust complaint and manufacturing investigations is crucial given the significance of complaint investigations during regulatory inspections.
(List the 6-8 most important responsibilities of the job. For each key responsibility indicate the action to be taken, the end result to be achieved, and how it will be achieved. Include the % of time spent on each responsibility. Total of percent should equal 100 %.)
1. Responsible for adequate and timely investigation of all Product Technical Complaints received from customers (65%)
• Manage complaint investigations received from worldwide markets and CMOs including from other Sanofi sites; responsibilities include:
1. Triage of the reported complaint with the assistance of Manager to determine the appropriate criticality and classification of the reported defect to assess potential risk to marketed product associated to the complaint(s)
2. Manage investigations by identifying required expertise (Production, MTech, Technical Services, QC, QOVS, QOSA, etc.) and leveraging the assistance of other departments or other Sanofi Pasteur sites to develop an investigational strategy
3. Review Batch Production Records and perform Root Cause Analysis as part of the complaint investigations; root cause analysis is performed by conducting process walks (GEMBA), selecting appropriate analytical tools and collecting and analyzing data to determine the true root cause.
4. Examine all returned product complaint samples and submit for testing
5. Ensure all product retention examinations are performed to assist with the investigation
6. Collaborate with the Global Pharmacovigilance department to determine potential adverse event assessments (as required)
7. Participate in Focus Factory Support teams for planning and execution of investigations, as required
8. Manage and coordinate sample shipment for investigational testing to be performed both internally and through external contract testing laboratories respecting required timelines to receive the result to apply to the complaint investigation
9. Develop appropriate corrective and preventive actions in collaboration with QO, various production areas and other Sanofi Pasteur sites
10. Identify reoccurring complaint defects and escalate as required for further corrective/preventive actions
11. Provide information to support the writing, review and submission of Biological Product Deviation Reporting (BPDR) to regulatory agencies
12. Manage the complaint review process and assists in ensuring that the complaint investigations are closed according to targeted timelines
2. Manufacturing Investigations (15%)
1. Identify all Manufacturing Investigation requests sent by the Global Pharmacovigilance department that require investigation and prioritize such requests based on the severity of the Adverse Event
2. Determine the various markets impacted by the distribution of the affected lot
3. Develop an investigational strategy for the Manufacturing Investigation
4. Execute Batch Production Record, Deviation, Change Control and Complaint reviews of the affected lot(s)
5. Coordinate any applicable activities with the Production areas
6. Manage the completion of the Manufacturing Investigation and ensure all investigations are reviewed and closed according to the targeted timelines
7. Collaborate with the Global Pharmacovigilance department to perform a periodic review of all Manufacturing Investigations and complaints to determine signal detection
3. Compliance and Performance (15%)
1. Ensure training is up to date to perform designated cGMP activities and based on Health and Safety requirements
2. Record data on GMP documents e.g. SAP work orders, maintenance task lists, etc. in an accurate, thorough and timely manner and compliant with established standards
3. Compile metrics data throughout the year for timely reporting
4. Update standard operating procedures and work instructions and ensure change controls are completed in time Participate in regulatory inspections and assist in ensuring responses and CAPA actions are completed within required timelines
4. Annual Product Quality Reviews (APQRs) (5%)
1. Provide complaints summary information to the APQR team to support timely completion of APQR reports
2. Provide other data/information for APQR reports as required by the APQR team or to support inspections and audits
(Required education, experience, certifications and competencies)
• Minimum Bachelor of Science degree, with specialization in Biology, Biochemistry, Microbiology, Immunology, Pharmacology, Chemistry.
• At least 5 years of pharmaceutical experience with related Quality experience in Quality Operations.
• Strong GMP background including working knowledge of GMP and interacting with regulatory agencies
• Knowledge and experience with multiple softwares/databases e.g. SAP, Trackwise, MS Ofiice (Word, Outlook, Excel, Visio, PowerPoint and Teams)
• Ability to think and act strategically in a fast paced environment and make balanced decisions related to quality.
• Ability to effectively communicate verbally and in writing through multiple layers of the organization; strong presentation skills is required.
• Excellent technical report writing and demonstrated ability to work independently
• Excellent organizational, interpersonal and teamwork abilities are required.
• Problem solving skills and analytical thinkings are essential skills for the role.
• Strong customer focus and ability to prioritize and adapt to business and manufacturing needs are required.