Quality Compliance Professional - Production (Concord)

Purpose: Ensure GMP compliance in API Production areas Responsibilities and Duties Review Batch Records directly during production phases Serve as liaison to production operators and shift leaders to provide support and guidance to ensure GMP compliance Communicate with Facility Maintenance team members to understand the control of the production environment during specific events that may impact the quality outcome of API Participate in the initiation or completion  of deviations investigations and risk assessments for product quality events to include conducting root cause analysis and performing interviews with appropriate employees Collaborate in the drafting / revision of SOP and MBR, verify correct GMP application and alignment of performed operations with written instructions Review all GMP documentation related to the production area Evaluate change proposals and implementation  Verify process documentation  Ensure continuous auditing of production areas Oversee correct application of equipment cleaning procedures Review process validation, cleaning validation and equipment / facility qualification protocols Report critical quality situations to supervisors, evaluate solutions and implement directives  Propose and monitor implementation and effectiveness of CAPAs related to area of responsibility Support client audits both during on site visits and during drafting of CAPA Plans Required Qualifications   Must have direct experience with Quality Assurance within an regulated industry (USDA, FDA, ISO etc) Understands and applies comprehensive knowledge of quality and GMP principles and maintains current understanding of global GMP drug manufacturing regulations BA/BS degree in Science related field or manufacturing is highly preferred, however, strong experience in Quality Assurance in a regulated industry may be considered in absence of a 4 year degree 5 plus years experience as a Quality Professional required PI9c326e6c5f