Specialist, Global Investigations Program Bilingual (Spanish/English)

Job Summary

This is a permanent role, responsible for the “Site review” and assessment of investigation reports on a real time basis to ensure, compliant, sustainable and consistent quality of GMP investigations as per regulatory requirements and expectations.

As part of Site Investigation Team (SIT) team, this role contributes to strengthen oversight to the site’s execution of Investigations, CAPA, and Surveillance processes.

Job Responsibilities

Site Review as part of SIT

• Completes Site level real time review, assessment and scoring of all aspects of Investigations including Deviations, LIRs, Complaints, CAPAs, using preapproved standard rubrics to ensure scientific rigor and discipline is applied to identify root cause for Investigations including proposal of effective CAPAs, prior to investigation closure. Submits the draft investigation report and completed rubric to the GIT on a timely basis to permit their review and feedback within the due date.
• Implement/reinforce Investigator and Approver Certification (IAC) rubrics / evaluation-based education and coaching for site Quality decisions on investigations and CAPA, drive continuous improvement and standardization across the organization.
• Ensures that investigations identify the true root cause based on Scientific rigor, Human Error causes are properly investigated, Impact and Risk level are appropriately assessed, and the corrective and preventative actions are commensurate.
• Ensures all comments from GIT are addressed in the final report and gets final approval from GIT before closure of investigation.
• Ensures that review of assigned number of investigation reports is completed as per required
• Works as a member of the Site Investigation Team (SIT) network to achieve a sustainable self-teaching model, to spread good investigation practices and to share learnings and best practices to Site/Function through the multiple established Forums at the sites.
• Acts as resource providing support and guidance to SIT, QA Approvers and Lead Investigators at the site
• Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance, and Passion; Demonstrate strong and visible support of our values.
• Performs all work in compliance with our Code of Conduct and Business Ethics, related policies and with the legal and regulatory requirements that apply to our job activities.

Job Requirements

• Education
  • Bachelor's degree in science or a related
• Apotex IAC Level 2 Certification: Investigation and CAPA Expert
• Knowledge, Skills and Abilities
  • Strong knowledge and application of cGMPs/GMPs in a pharmaceutical manufacturing and in QA/QC environment
  • Deep understanding of Investigation process and CAPA management
  • Demonstrated ability to work independently and effectively manage multiple priorities in a fast paced and changing environment.
  • Excellent interpersonal, communication, presentation, and facilitation
  • Critical thinking and application of scientific reasoning
  • Demonstrated ability to work in partnership with and build strong links to all areas of the business. Ability to provide effective feedback and coaching to others.
• Experience
  • Minimum of 5 years of regulatory compliance and quality experience in the pharmaceutical or related industry with experience in quality, production or laboratory systems
  • Minimum 3 years of practical experience in Investigations