Client: A renowned global pharmaceutical organization.
Key Responsibilities:
Responsible for vendor management and the oversight of the organization's external manufacturing portfolio.
Provide Quality oversight by thoroughly examine lab results, product stability, and processes. Lead process investigations, and guide the corrective actions (CAPAs) to make sure the problems are solved at their source.
Conduct Field Alert Report (FAR) assessments, lead critical meetings, and manage the escalation of serious issues, including detailed technical reviews.
Drive the continuous improvement efforts on the organization's Quality Management Systems (QMS) and support audit readiness activities.
Encourage a culture that values high standards and continuous growth.
Key Qualifications:
Minimum of 7 years of quality experience in pharmaceuticals, medical device or combination products in a GMP regulated environment.
Strong hands on experience in handling external manufacturing organizations/third party vendors.
Strong knowledge and experience in investigations, Change Controls, and CAPA management is a must.
Bachelor's degree in a relevant discipline (biological sciences, Pharmaceutical studies or equivalent).
Strong knowledge in FDA regulations (including 21 CFR Part 210, 211, 820).