Understanding of Good Manufacturing and Laboratory Practices, FDA regulations, SOPs, and current compliance standards.• Ability to audit documents, procedures, and records for accuracy and continuity• This position requires a B.S. degree and 3-5 years' experience in pharmaceutical manufacturing or 4-8 years of equivalent experience
Responsible for working cross-functionally with Manufacturing, Process Engineering, Facility, Inspection and Project Management on Quality Assurance (QA) activities such as the following: o On-the-floor support and oversight of manufacturing operations o Executed/Unexecuted Batch Record Review. o Executed/Unexecuted Validation/Facility Protocols/Reports. o Reviewing Facility Work Orders prior to filing. • The QA Specialist III works in coordination with the QA Management to ensure client timelines are on schedule and attainable. • Assist in responsibility for the compilation of documentation, systems and controls to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for domestic and international inspections and registrations. • Reviews Un-executed /Executed batch records and quality control testing for compliance with internal SOPs and specifications • Monitor Operations personnel for adherence to SOP's. Report back to Manager of QA as well as area functional management as to personnel performance, highlighting those areas and individuals in need of improvement • Reviews and approves Document Change Notifications for SOPs, test methods, raw material specifications, protocols (stability, validation, etc.)and batch records • Reviews and approves SOPs, test methods, raw material specifications, protocols and executed validation documentation • Authors or revises SOPs • Performs manufacturing area and labeling clearances as well as inspection of material • Reviews and approves CAPAs, Deviations, Change Controls, Equipment Excursion Reports • Assists in performing investigations • Performs internal audits and weekly walkthroughs • With supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues • Assists in developing and delivering training • Assists tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs • Develops and/or maintains Quality System metrics for Management Review • Provides on the floor support to manufacturing operations • Perform QA visual inspection activities associated with clinical and commercial drug product. • Participate in regulatory and client audits.
Source: Job Diva – Job Listing