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Amneal Pharmaceuticals Operations Compliance Reviewer in Brookhaven, New York

Description: * The Operations-Compliance Reviewer is responsible for reviewing, collecting detail information related to Unplanned Deviation and discuss with Operations Compliance team. Essential Functions: * Review the production in-processes, handling of material during operations, storage, and handling of products & materials through investigation processes to assure products conform to established requirements and standards. * Complete review tasks within specified time frame without compromising quality of audit. Report all findings during review and reports to the team. Prepares weekly/monthly status reports for departmental updates/meetings. * Responsible for assisting, working independently in the resolution of quality related issues by gathering relevant information, determining the accurate cause. * Follow up with the cross functional department by arranging meetings or interviews in response to investigations and alerts. * Responsible for Compliance tools – Qumas and Caliber to mange task as assigned for NY plants. Initiate planned Deviation and Unplanned Deviation Through CaliberQams Software. * Responsible for CAPA and Planned Deviations completion and follow-up to specific department and facility. * Review Production batch records with respect to written procedures/specifications, SOPS, and company policies. * Identify objectionable cGMP issues which may impact product quality and escalate the issues to Operations Compliance team in a timely manner. Additional Responsibilities: * Continuously improve the documentation system to increase efficiency and GDP compliance. Education: * Bachelors Degree (BA/BS) Preferably in Pharmaceutical Science, writing or related degree - Required Experience: * Less than one year in Working in cGMP regulated pharmaceutical particularly in operations - Preferred Skills: * High energy level, good organization skills and must be result oriented - Intermediate * Excellent technical written and verbal communication skills and able to handle multitask and multiple priorities - Intermediate * Ability to work with cross functional department - Advanced * Ability to work flexible hours as and when needed - Intermediate * Willing to travel between NY Amneal locations as needed - Intermediate * Microsoft Office/ Computer - Intermediate Job: Operations Mgmt* *Organization: Operations *Title: *Operations Compliance Reviewer Location: NY-Brookhaven Requisition ID: 210HB

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