Lead Investigator

Overview

Almac Group is currently seeking a Lead Investigator for our Durham, NC location. The role of the Lead Investigator is integral to the success of the Pharmaceutical Quality Management System in ensuring that Deviations and Complaints (QEs) and resultant Corrective Actions and Preventative Actions (CAPAs) are initiated, investigated, documented and closed out in a timely fashion to prevent recurrence and to ensure customer satisfaction. The investigation process will involve impact assessment and evaluation of risk.

Responsibilities

• Conduct investigations into reported incidents to assess the impact and identify immediate actions to limit the issue.
• Perform trending to identify recurring issues and establish the cause(s) and contributory factors using appropriate root cause analysis tools.
• Identify appropriate CAPA to prevent recurrence and document investigations in a timely manner using authorized tools and systems. Ensure details are captured succinctly and logically for approvers, customers and / or regulators.
• Fulfill the role of the Lead Investigator for assigned incidents, including :
• Visit the area (GEMBA) where the incident was detected when applicable
• Interview all involved individuals and obtain background knowledge to fully understand the process
• Document findings in accordance with GMP principles and internal SOPs
• Provide regular updates to department managers and escalate identified regional or global trends
• Participate in customer teleconferences to discuss incident details and provide updates when explanations or revisions are required
• Liaise with appropriate personnel to gather information and promote a culture of openness
• Escalate any critical issues to the appropriate Departmental and Quality Management as they become apparent
• Monitor the progress of investigations and take ownership to ensure timely closure; escalate delays as needed
• Complete CAPA effectiveness checks and document necessary evidence; escalate to management if effectiveness cannot be confirmed
• Foster inter-departmental and global collaboration to ensure global consideration of investigations and CAPA
• Attend periodic meetings with other Lead Investigators and contribute ideas for continuous improvement
• Contribute to process improvement discussions during Risk Assessments and SOP development

Qualifications

Required Experience / Education :

Preferred Experience / Education :

What can Almac Group offer you?

Almac is an equal opportunity employer dedicated to diversity and inclusion. We provide reasonable accommodations to people with disabilities who need assistance completing the application process. Please email ADARequest@almacgroup.com to request assistance.

Almac Group, Inc. is an Equal Opportunity Employer - Minorities / Women / Protected Veterans / Disabled. EEO is the Law. EEO is the Law GINA Supplement.

RECRUITMENT AGENCIES PLEASE NOTE : Almac will only accept applications from agencies that have been invited to work on this role through our portal. Candidate resumes / CVs not submitted through our portal or directly to Hiring Managers will be considered unsolicited.

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