Overview

Quality Assurance and Regulatory Affairs Specialist (Marlboro, MA)IT&Pharm Reg company. Masters+2 year exp (Regulator affairs, Quality assurance, Pharma Sciences or related).Analyze raw materials, in-process and finished product samples, process validation samples and water samples per the established procedures; Conduct internal audits for compliance with SOP, cGMP & FDA requirements; Work with advanced equipment such as HPLC and GC systems,UV-visible, spectrophotometer and similar. Monitor critical equipment and instrumentation, write and update inspection procedures and checklists as necessary. Prepare reports, documents and papers by interacting with scientists and maintaining ICH guidelines, US FDA and Health Canada regulations. Prepare and review of IQ, OQ, PQ and QC/manufacturing documents. Publish, submit and maintain regulatory filings in coordination with Global Regulatory Leads. Ensure that compliance standards are met for receipt and delivery of information to and from external consultants and health authorities. Control submission component receipt and workflow completion to ensure a high quality final submission. Dispatch submissions through the FDA Gateway. Required experience in working with HPLC and GC systems and UV-visible, spectrophotometer equipment. SOP, CGMP, IQ, OQ, PQ and QC. Experience in FDA and ICH regulations pertaining to regulatory and technical requirements for electronic submissions. Apply with 2 copies of resume to Human Resources, Vividstrats, P.O.Box 853, 73 River St, Marlboro, MA 01752.