Job Requirement
• Create and establish a scientific approach to the company quality system.
• Perform review and release of API and excipients in support of manufacturing.,
• Establish training and audit programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports and manufacturing records.
• Review and approve Master documents such as Master Batch Records, In-process forms, Method Qualification Protocols, Method Validation Protocols, test methods, reference standards and other related documents.
• Provides guidance and training for other Quality Assurance staff in the accomplishment of Quality Assurance operation activities.
• Act as company’s representative during regulatory agencies and customer inspections
Qualifications
• BS degree in Chemistry, Life Science or related discipline and a minimum 1-5 years of QA/validation experience in an FDA regulatory Industry.
• Familiar to solid dosage pharmaceutical manufacturing process with thorough understanding in GMP
• Strong technical writing skills and the ability to clearly express ideas in English.
• Local Candidates preferred.
732-429-1858
eayache @ irionline.com
http://www.irionline.com
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.