Our client is currently recruiting a QA Manager to provide leadership and energy to its Quality Assurance team. This is an exceptional opportunity to join a corporate culture that is known for having an innovative and growth oriented vision. Responsibilities include:
1) Ensure full quality and regulatory compliance of a facility, while driving process effectiveness and efficiency at the site
2) Ensure site audit readiness and host the quality system audits, prepare and execute quality management system reviews
3) Maintain positive agency relationships-liaisons with regulatory agencies upon site inspections and participates in external technical forums
4) Perform inspection of drug product rejects/complaint investigation samples as part of QA investigations
5) Collaborate with internal departments and across sites to ensure understanding of operating standards and execute requirements of quality system processes
6) Represent quality assurance on multidisciplinary project teams as assigned
7) Contribute to process improvement initiatives across organization - provide support and direction to maintain quality system to recognized standards - direct and/or participate in development of QA processes and SOPs
8) Assist in development of guidelines and standards on an international level
9) Lead and participate in quality improvement projects
10) Evaluate existing QA policies and procedures and make changes where applicable
11) Plan, prepare and perform internal and external system audits as well as study-related audits
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