Take on a key role at Resilience Biotechnologies as a Regulatory Deviations Specialist, focusing on deviation records and compliance verification. Collaborate with cross-functional teams to maintain quality standards.
As a Deviations Specialist on an 18-month fixed-term contract, you will execute deviation investigations and analyze data for root causes, partnering with various departments for seamless operations. Your expertise in GMP and regulatory requirements will be essential for timely project completion.
Key Responsibilities:
• Document and manage recurring deviations efficiently
• Craft clear deviation investigation reports
• Develop and execute Root Cause Analyses as needed
• Work with stakeholders to devise effective CAPAs
• Oversee deviation closeout processes to meet timelines
Requirements:
• Diploma with over 3 years of pharmaceutical experience or a B.Sc.
• Robust background in RCA and CAPA methodologies
• Familiarity with GMP practices in biopharmaceuticals
• Previous interaction with regulatory agencies like FDA
• Proven track record in handling documentation and quality control
Enhance your career by addressing complex quality challenges at Resilience Biotechnologies.
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