Job Details

Job Title: Senior Deviation Investigation Specialist

Duration: 6 Months

Responsibilities

• Conducts Minor / Major / Critical Deviation investigations in their respective areas as necessary and documents such investigations appropriately
• Collects raw data and information needed to process the investigation
• Leads Root Cause Analysis to identify the most probable root cause, determine product impact, and assign appropriate CAPAs with responsibilities and due dates
• Performs trending to identify and report adverse trends that may require further action
• Writes the investigation report and completes investigations within the specified time-frames
• Develops corrective and preventative actions to prevent problem recurrence and establishes an effective follow-up system to ensure corrective and preventative actions have been implemented and are effective
• Manage client communications efficiently and effectively, to obtain timely approval of investigation reports
• Reports work progress and performance metrics to Project Leader on a daily and weekly basis

Requirements

• Bachelor's degree from an accredited college/university
• Appropriate written and verbal communication skills in English and in any other relevant language(s)
• +10 years of experience in Aseptic Processing facilities, with proven expertise in production deviation investigation and report writing
• Expert level understanding of deviation resolution for manufacturing processes and CAPA management
• Previous experience with remediation plans for the US FDA
• Expertise in other QA tasks that include PQR, auditing, change control, complaints management, OOS, batch record review, documentation management, training, supplier management)
• Collaborative team player with a strong focus on achieving KPIs and project goals while effectively navigating conflict and driving win-win resolutions