Method Validation

Consulting Worcester, Massachusetts


Description


Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

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. 



Description:

Method Validation/Method Transfer: 

  • Perform method validation and method transfer activities for a pharma client.
  • Work cross functionally to review analytical data and help make decisions on method transfer.
  • Generate protocols and execute them as required.
  • Draft the final reports and/or assessment for the method validation.


Education: 
• Minimum requirement of a Bachelor’s degree.

Experience: 
4-6 years in Method Val/Method Transfer. 
• Pharmaceutical & FDA/GLP industry experience. 
• Demonstrated understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines. 
• Ability to keep neat, accurate and complete records and logs. 
• Must be proactive, results oriented, with a strong attention to detail. 
• Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team. 
• Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment. 
• Strong organizational, analytical, troubleshooting and problem-solving skills. 
• Ability to analyze details and perform structured decision-making on a daily basis. 
• Excellent verbal and written communication. 
• Must be able to read, write, and speak English. 
• Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner. 

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