Quality Auditor

Description:

Quality Auditor Role:

• Conduct routine audits of data, information, procedures, equipment and systems (including computer systems), and/or facilities to ensure the compliance with SOPs and GMPs and worldwide regulations.
• Review and approve production and analytical documentation accompanying the release of API, Safety Assessment or clinical supply lots (bulk and packaged) to ensure conformance to appropriate regulatory requirements.
• Communicate and resolve audit comments with client areas.
• Under supervision, or as part of a team, perform audits or inspections of assigned areas or systems to assess compliance with regulatory and Company standards.
• Issue reports summarizing deficiencies and work with areas to execute remedial action.
• Notify appropriate management of inspection result.

Your Background:

• Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency.
• Working knowledge of cGMP regulations. E
• Effective communications (oral/written) and interpersonal skills are essential.