CQV Consultant

Azzur Group is a GxP compliance and consulting organization focused on providing quality-driven solutions that propel life science companies toward success. If you're a dedicated professional with a desire to engage, learn, and adapt within a dynamic healthcare landscape, you will fit right into our core values: Put Others First, Have the Courage to Take Action, Take Personal Responsibility, and Have Fun!

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. 

Requirements

• 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

Benefits

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)