As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we are seeking a Specialist, New Product Introduction to join our Quality team.
What You'll Be Responsible For
- Conducting Due Diligence for M&A; and NPI projects from a quality perspective, ensuring:
- Identification of gaps during DD and highlighting risks associated with the project
- Identification of tasks associated with the project during Integration
- Enable a data-driven process that provides ease in determining and reporting identified risks, pending tasks, and overdue actions for project managers and task owners.
- Identify risks that can impact the timely launch of product/project and its mitigating actions
- Prepare and execute regular monitoring of KPI’s for all M&A; Integrations and NPI for the Quality team.
- Support in the management of documents and templates associated with M&A; and NPI from Quality perspective.
- Participate actively in cross-functional meetings relating to M&A; and NPI projects from Quality perspective and execute assigned deliverables within agreed timelines.
- Leading Bi-weekly / monthly meetings for both M&A; and NPI within Quality.
- Other activities that may be required at the discretion of management, supporting Quality activities.
- Provide support during inspection by competent authorities.
- Review and approve assigned Deviations and CAPA to ensure compliance with relevant guidelines and ensure patient safety.
- Thrive in an entrepreneurial environment, and take accountability for results.
- Have a bias for action and rapid decision-making.
- Consistent demonstration and embodiment of the company's core values: Entrepreneurship, Speed, and Integrity.
- Drive the spirit of “One Team” by working collaboratively across all business functions with