Summary Provides expertise, guidance and oversight for both the Validation and Quality Engineering efforts at Akorn, Decatur. Responsible for the development and implementation of the Decatur Validation Department and the Site Validation Master Plan. Keeps abreast of industry "best practices" using resources, such as ISPE and PDA' continuously upgrades the Site's validation practices and procedures; and ensures Site compliance with current FDA regulatory requirements. Responsible for the development, obtain management approval and execute a Quality Engineering plan consistent with the Site business plan. Keeps abreast of industry "best practices" and trends in Quality Engineering, such as Six Sigma and Lean Manufacturing. Has the expertise to work with all levels of management, staff and internal departments including outside contractors and vendors, as applicable. Essential Functions 1. Provide expertise in the development, execution and review of validation protocols. 2. Develop and maintain a requalification schedule for facilities, equipment and processes based on a risk assessment, current industry "best practices," and regulatory requirements. 3. Able to schedule staff to meet aggressive validation timelines. 4. Responsible for the maintenance and implementation of the Akorn Decatur Validation Master Plan Schedules, including facility, equipment and process requalifications. 5. Responsible for the review, approval and recommendations for further actions, as necessary, on Engineering Change Requests. 6. Excellent working knowledge of cGMP requirements on validation methods and principals including ISPE, GAMP guidelines and FDA, CFR Part 11 Electronic Records and Signatures requirements. 7. Able to hire, mentor and train staff and other resources as needed. 8. Able to develop and write applicable validation documentation, including, but limited to URSs, FDSs, DOEs, FATs, lQs, OQs, PQs, VQs from scratch/manuals, if not readily available. 9. Good working knowledge of Quality Engineering tools, such as Six Sigma and Lean Manufacturing. 10.Able to handle multiple, complex projects and work independently. Education and Experience At minimum, a BA or BS Degree in Engineering, Chemistry or Microbiology with preference for the Engineering Sciences from a four year college or university. Certified Engineer or CQE is a plus. A minimum of 10 years experience in a management level position in the pharmaceutical industry. Sterile injectables experience required.
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