The Quality Technician will assist the QA officer in the review of procedures, completed batch paperwork including manufacturing and analytical documentation. Be the QA representative for new campaigns dealing with aspects including process instruction sheets, change control, deviation, validation, customer audits, raw material and final product disposition. The QA Technician is expected to identify and escalate cGMP issues that have the ability to effect batch quality.
Role
•Provide QA input to project activities including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing Procedures and Analytical Procedures.
•Participate in quality related investigations, assist in the development and approval of effective CAPA in order to resolve production, audit and customer issues.
•Identify and escalate any identified cGMP areas of concern.
•Participate in validation activities including approval of protocols and reports for analytical methods, manufacturing processes, analytical / production / packaging equipment and cleaning procedures
•Participate in the audits of suppliers, production and support functions as required.
•Be involved in the preparation for MHRA/FDA and other regulatory body audits.
•Review the relevant documentation relating to incoming raw materials and perform the disposition activities as required.
•Reviewing manufacturing, laboratory and associated documentation prior to performing the relevant disposition of final products.Where potential issues exist, these are to be highlighted to the QA manager.
•Act as the QA representative for the introduction of new products, being a key member of the multi-functional team including R&D, QC and manufacturing thus ensuring that all cGMP documents are appropriate and all cGMP requirements are satisfied.