What are the responsibilities and job description for the Operations Compliance Reviewer position at Amneal?
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.
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