QA Associate

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