Arbetsbeskrivning

Urgent requirement with our direct client. If interested please send your updated resume to disha@irionline.com .

DIRECT CLIENT NEED – Immediate interview!!!

Job Title: Scientist IV

Location: RARITAN /

NJ

Duration: 09 months+

Summary:

The Technical Operations Contractor is responsible for technical aspects of the Lifecycle Management structure and strategy for parenteral drug products including SIMPONI pre-filled syringes, STELARA pre-filled syringes, and Risperdal Consta Injection.

The candidate will provide this technical support at U.S. based contract manufacturing sites such as Baxter Bloomington, IN and Alkermes, Wilmington, OH.
The candidate will support technology transfers, implementation of continuous process verification programs, investigations, change control initiatives, and continuous process improvement programs.

FUNCTIONAL KNOWLEDGE, SKILLS, AND ABILITIES :
• Strong expertise with regard to pharmaceutical products & manufacturing processes with a focus on parenteral products
• Good knowledge regulatory requirements and GMP’s understands the technical aspect of the lifecycle strategy of products
• Applies the science based risk approach and regulatory/GMP intelligence
• Ability to create, maintain, and upgrade product technical knowledge and author documentation regarding these activities
• Ability to monitor technical process and product performance across internal and external manufacturing sites and employ statistical methods to assess
• Ability to participate in risk assessments with a quality and compliance perspective