Abbott is looking to solve the problem of ensuring the accuracy of quality documentation within their manufacturing plant, specifically focusing on new product registrations, change management, batch record review, and product release to maintain best practices for quality document control and compliance with regulatory standards.
Requirements
- Must have demonstrated solid knowledge and experience in the discipline
- Considered a Subject Matter Expert and key contributor to initiatives.
- Leader and key contributor to initiatives and advancement of the Quality organization.
- Makes decisions and charts a course through careful evaluation of risks and benefits with limited information in conjunction with the Site QA Director.
- Ensure that all QA documents meet established Abbott and regulatory standards and that these documents are stored in an effective system.
- Identify gaps in Plant Documentation and systems and take necessary actions to correct.
- Responsible for Executive Leadership activities – setting strategy for teams, employee development, and effective change management in relation to quality documentation.
Responsibilities
- Responsible for the detailed end-to-end review of all batch documentation to ensure compliance with all policies, procedures, and regulations related to the product up to and including CAPA, interventions, and environmental monitoring data prior to batch release for commercial distribution.
- Accountable for Batch Release Process Management, which would include identifying all batch non-conformances and initiating appropriate actions for those non-conformances.
- Control the release of product to market and coordinate the quarantine of nonconforming finished products.
- Maintenance of batch release, discrepancy, and non-conformity metrics and tracking MSP performance with other site departments.
- Review and approval of all change requests to site-related documentation and assessment of all Corporate and Divisional policy updates.
- Partner with affected groups to ensure change control is maintained and site training is updated to reflect changes.This would include new product introductions, label copy adherence, and product certification.
- Accountable for maintaining the site Documentation system and QA Work Order systems.
Other
- Bachelor's degree in a scientific or technical discipline
- 7+ years of experience in a function or related field.
- 4+ years of direct supervisor experience.
- Builds/drives relationships and teamwork within the team and across functions with a professional demeanor.
- Yes, 5 % of the Time
