Job Description

Job purpose

This position is responsible for ensuring products are manufactured, inspected, tested and packaged according to GMP and Company requirements. This is done on a day-by-day basis by the ensuring non-conformance investigations and product complaint investigations are managed in compliance with Taro Global Quality Policies, GSOPs, SOPs and Regulatory requirements. This position is also responsible for the oversight of the site wide CAPA Management Program.

Principal Duties and Responsibilities:

• Provide leadership to team through employee development and performance management as well as establishing a culture of Quality.
• Lead Site Investigation Review Board ensuring that the Board is acting as an independent investigation review cross-functional organization at the site
• Facilitate and execute investigations review and approval and audit activities as per the established plan
• Design meaningful metrics and perform Site Investigation Management Program effectiveness check and report its outcome to the Quality and Operations site leadership at the established frequency
• Obtain and keep current Lead Investigator and Approver certification status as per the Certification Program requirements
• Develop structured cross-functional matrix of the Lead Investigators, Reviewers and Approvers at the site ensuring sufficient amount of the personnel involved in the Investigation Management Program
• Appoint Lead Investigators from all GMP functions and ensure their timely certification and execution of the appropriate training and coaching; periodically assess performance of the certified Lead Investigators and Approvers and propose corrective actions as an outcome of this activity
• Ensure appointment of the Subject Matter Experts (SMEs) from the supporting departments (Operations, QC, Warehouse etc.) and their participation in the investigations execution and Board discussions
• Lead all activities associated with Investigator and Approver Certification Program
• Manage TrackWise access and system training of the site personnel involved in the investigations based on their training and certification status, perform the role of the TrackWise Superuser at the site
• Ensure assessment of the CAPAs effectiveness and timely execution of all the associated actions
• Support decision making on the product recall as an outcome of the investigation including strategy, justification, risk assessment; participate in the Site Recall Committee
• Identify relevant regulatory requirements for non-conformance investigations and ensure their implementation in Taro Canada
• Participate in Internal, Customer and Regulatory Audits.
• Other duties as assigned

• Experience in dealing directly with Regulatory Agency officials (Health Canada, USFDA, MHRA)
• Sound knowledge and application of Health Canada and FDA regulations
• Knowledge of pharmaceutical standards, transfer guidelines, validation requirements
• Good organizational skills and multi-tasking ability
• Excellent written and verbal skills
• Good interpersonal and negotiating skills

• Minimum of B.Sc. Chemistry or other associated field.
• Minimum 8 - 10 years' experience in a supervisory/management level in the pharmaceutical industry
• Experience in management of a comprehensive investigation process

• Non-routine and complex problems:
• problems associated with production issues that could range from scheduling problems to errors in production
• non-compliance investigations
• Problems associated with dealing with individuals from multiple departments, and working on various functions within and outside Taro Canada.

• Stress tasks and environment during regulatory and customer's inspections
• May act as back up to the Director Quality Compliance
• Regular Presence on manufacturing/packaging shop floor, as needed