Lead Investigator Deviation

TATA Consulting Services • Indianapolis, IN

59d • $85,000 - $110,000

About The Position

Leading investigations into manufacturing or quality process deviations to determine the root cause, develop Corrective and Preventive Actions (CAPAs), and ensure thorough, timely, compliant documentation (deviation report), all while collaborating with cross-functional teams. Driving improvements to the deviation investigation process and maintain GxP processes. Present/provide investigation findings, progress, and strategies to management

Requirements

• Pharma Domain Understanding
• Vault QMS and/ Or TrackWise Knowledge
• Change Control
• Incident, Problem Management
• Root Cause Analysis Techniques
• Cross Functional skills
• Project Management

Responsibilities

• Leading investigations into manufacturing or quality process deviations to determine the root cause
• Develop Corrective and Preventive Actions (CAPAs)
• Ensure thorough, timely, compliant documentation (deviation report)
• Collaborating with cross-functional teams
• Driving improvements to the deviation investigation process
• Maintain GxP processes
• Present/provide investigation findings, progress, and strategies to management

Benefits

• Discretionary Annual Incentive.
• Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
• Family Support: Maternal & Parental Leaves.
• Insurance Options: Auto & Home Insurance, Identity Theft Protection.
• Convenience & Professional Growth: Commuter Benefits & Certification & amp; Training Reimbursement.
• Time Off: Vacation, Time Off, Sick Leave & Holidays.
• Legal & Financial Assistance: Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees