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Job Responsibilities:

• Conducts Minor / Major / Critical Deviation investigations in their respective areas as necessary and documents such investigations appropriately
• 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
• 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
• Reports performance metrics to Project Leader on a periodic basis

Detailed Job Description:

• Bachelor’s degree from an accredited college/university
• Appropriate written and verbal communication skills in English and in any other relevant language(s)
• At least 7 years of experience in Pharmaceutical industries, with biologics and/or biotech products preferred
• Knowledge and experience with aseptic processing
• Expert level understanding of deviation resolution for manufacturing processes and CAPA management
• Previous experience with remediation plans for the FDA
• Expertise in other QA tasks that include PQR, auditing, change control, complaints management, OOS, batch record review, documentation management, training, supplier management)

Experience required: 5 Years