• High School Diploma / GED
• Minimum of 3 years of experience in a regulated production facility.
• Proficient with MS Word and Excel.
• Technical understanding of equipment in a Manufacturing environment
• Good knowledge of cGMPs.
• Able to manage their time and complete projects on time.
• BS Degree in Science, Engineering, or related field.
• Experience in a leadership role in a regulated production facility is preferred.
• Proficient with Trackwise preferred.
The Operations Compliance Improvement Lead will support the deviation management for the Operations Departments (Manufacturing and Packaging). To ensure that Operations Departments (Manufacturing and Packaging) remain compliant and up to date on audits, CAPA and CAPA effectiveness.
PLEASE NOTE: The hours for this position are 10:30pm -7am.
• To initiate deviations with relevant problem statements and appropriate attachments to support the site deviation management process.
• To investigate deviations using RCA tools such as fishbone and 5 why analysis and write compliant deviations to pharmaceutical standards.
• To assist the manufacturing and packaging departments with production issues as required.
• To update / create procedures and/or forms as required.
• To run metrics and ensure all CAPA for the manufacturing and packaging departments are completed accurately and on time.
• To develop a process to ensure CAPAs are effective.
• To carry out a periodic review of the CAPA for the departments and present that information to the Operations Support Manager and Department Managers.
• To support the sites Level 1 and Level 2 audits as necessary.
You may apply for this position online by selecting the Apply now button.
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