Main function is release of raw materials intended for Manufacturing. Assists in the preparation of Standard Operating Procedures (SOPs). Assists in the documentation of Non-conforming events (NCEs).Reviews laboratory test data and performs inspections in accordance with current Good Manufacturing Practices (GMPs), Evaluates systems and procedures as assigned in consultation with Supervisor.
Reviews all receiving documentation provided by Logistics for conformance to Specifications.
Assures that correct product labels have been generated by Logistics
Confirms accuracy of information entered by Logistics into inventory management system in order to provide disposition
Reviews inspection and testing data and provides disposition of materials after all release criteria have been evaluated. Evaluates the need for sampling/inspection of material by QC group Files and distributes certificates of analysis as required. Scans completed quality documentation into controlled locations Participates directly in audits of assigned areas. Inspects in-house areas, discusses conditions/practices with appropriate personnel, documents and reports findings to Management and follows-up as needed. Provide quality input into investigational and CAPA tasks Participate in quality and process improvement initiatives, and project teams Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.) Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required Ability to work in a team environment and independently as required May be required to work Holidays and weekends May be required to work Overtime Contributes to the overall achievement of departmental goals. Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures. Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices. Performs other duties as assigned
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
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