Job Opportunity
We are seeking a skilled professional to provide quality direction and oversight for new equipment introduction, technical transfer, and lifecycle management.
* Lead the quality assurance process for all aspects of new equipment introduction, ensuring compliance with regulatory and company standards.
* Collaborate with cross-functional teams to ensure robust validation documentation and effective change control implementation.
* Develop and implement risk assessment strategies to mitigate potential challenges in equipment introduction.
Requirements
* University degree in a Science or Engineering-related discipline.
* Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry.
* Proven expertise in new equipment introduction, technical transfer, PPQ execution, and lifecycle management.
* Strong understanding of validation principles and regulatory requirements (FDA, EMA guidelines).
* Experience with change control, non-conformance resolution, and CAPA implementation.