MAIN RESPONSIBILITIES

? Responsible for implementing and maintaining the effectiveness of the quality system and for providing Quality Assurance design review support to product development projects.

? Overall responsible for batch records auditing and product release process within the pilot plant operations scope, including handling, documenting and addressing nonconforming material and other quality issues.

? Lead or participate in investigations to resolve and troubleshoot operational exceptions.

? Develop systems to track, trend, report and reduce nonconforming situations.

? Support the resolution and approvals of exception reports and manage the identified corrective and preventive action plans for all nonconformities.

? Ensure that the validation program is executed consistently in line with Abbott Validation Policies, and assist in the maintenance of the Validation Master Plan.

?Provide a broad base of Quality Assurance support for all validation activities, including coordination of validation-related training,

? Perform Quality Assurance roles for maintenance and calibration activities, as required by the Instrument Calibration Policy.

? Monitor compliance to validated systems such as Facility/Utilities/Equipment qualifications, process validations, procedures, drawings, calibrations and software. Ensure compliance to division and corporate requirements for GMP, environmental cleanliness, product quality and hygiene standards. Define, develop and implement the HACCP process for pilot plant operations. Identify, analyze, and implement solutions to process challenges tied to compliance.

? As required, manage and maintain compliance to CFR 21 Part 11 requirements for computer validation.

? In conjunction with the regional Compliance Manager, develop and maintain the annual internal audit program schedule. Coordinate and perform Internal and GMP audits as per schedule.

? Audit validation packages, maintenance work orders and other related documents that may be subject to Corporate or Regulatory audits.

? Manage the documentation system and requirements for assigned operations. Ensure all QA documents meet established divisional, corporate and regulatory requirements, and are current and up to date.

? Identifies any gaps in the documentation system and take necessary actions to correct and improve. Develop and improve on the documentation routing process to assure timely implementation of requested changes.

? Assist with the development of Master Work Orders, CIP process and procedures and Deviations as necessary in support of R&D processes.

? Manage the Quality Management Review process for the assigned operations group, and follow up on all items assigned during Management Review meetings as well as special projects as assigned.

? Be the main point of contact with groups outside of R&D, such as Medical, Regulatory, etc.

? Understand and apply industry regulations knowledge with an understanding of the business operation to achieve regulatory compliance.



Experience

?Possess a thorough knowledge of Quality Assurance and Manufacturing processes (production, logistics, engineering and performance metrics).

?Possess technical understanding of different technologies, manufacturing quality systems and Clinical Operations and is able to provide consultation and recommendations to help improve compliance. Prior experience in pilot plant operations would be highly desirable.

?Have experience in documentation review, for documentation control and for batch release purposes.

?Have experience in performing/leading audits and working independently through troubleshooting issues.

?Ability to successfully interact and communicate with all organizational levels internally and externally.

?Demonstrate the ability to manage several activities / projects at once, to organize / prioritize work, to meet deadlines and to prepare plans and reports.

?At least 8 years of relevant QA experience in a regulated environment such as pharmaceutical or food is preferred.