QA Chemist Job

QA Chemist is needed to perform the following duties:

• Scientifically analyze raw materials, in-process & finished product samples, process validation samples and water samples as per establish procedures under close supervision of senior chemists/scientists;
• Conduct internal audits in a group setting & under guidance from senior chemists/scientists for compliance with SOP, cGMP & FDA requirements;
• Assist in drafting SOP’s by researching new regulatory guidance and cGMP and by preparing reports for senior chemists/scientists to review;
• Conduct initial review of IQ, OQ, PQ and QC/manufacturing documents. Will prepare detailed scientific reports for review by senior scientists;
• Work with advanced equipment such as HPLC and GC systems, UV-visible, spectrophotometer etc.;
• Follow guidance from experienced chemists/scientists and assist them in researching & developing validation protocols and test procedures by performing lab experiments, chemical analysis of materials, preparing test solutions, conducting QC/QA tests etc. to ensure products meet with appropriate regulatory agency validation requirements, internal company standards and industry current practices;
• Review scientific data from R&D/manufacturing operations and prepare drafts of batch manufacturing and packaging records for review & approval by experienced chemists/scientists;
• Calibrate/check critical laboratory equipment and instrumentation and assist in drafting/updating inspection procedures and checklists as necessary;
• Review and analyze (chemical analysis & tests) any departure from established procedures and investigate any product failures under guidance of experienced chemists/scientists;
• Approximately 85% of the time will be spent in scientifically analyzing raw materials, in-process and finished product samples, validating results, conducting internal audits and implementing SOP’s under close supervision and guidance of experienced chemists/scientists. Approximately 15% of the time will involve preparing scientific/technical reports, documents and papers and conferring/interacting with scientists and maintaining ICH guidelines and US FDA regulations.

Bachelor''s degree is required in Pharmacy or Pharmaceutics or Chemistry or Pharmaceutical Science