CQV Consultant
Description
From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.
Essential Duties and Responsibilities:
- Responsible for writing investigations, deviations, CAPAs and Change Controls with client input.
- Develops Validation Plans for small to medium size validation projects, qualification of equipment, facilities, utilities, as well as cleaning sterilization, and manufacturing process validation.
- Performs on site or support work for a client under minimal supervision.
- Validation protocol execution for FAT/SAT/IQ/OQ/PQ, thermal mapping of temperature controlled chambers, warehouses, and sterilization processes.
- Initiates and performs investigations to close out deviations.
- Ensures corrective actions are resolved in a timely manner.
- Supports the resolution of regulatory observations or manufacturing site issues.
- Performs such onsite activities as P&ID Walkdowns and PPQ
- Provides assistance with project management for commissioning, qualification of new engineering systems.
Qualifications:
- Bachelor's degree in sciences or related field required, Bachelor's degree in Microbiology preferred
- 4-10 years’ relevant experience in a regulated pharmaceutical industry including PPQ
- Good command of the English language required. Fluent in any other languages a plus