Lead validation strategies and quality initiatives for new product introductions, technology implementations, process improvements, and manufacturing changes to ensure compliance and product quality.
Plan, execute, and review validation activities, including Process Validation (IQ, OQ, PQ), Computer System Validation (CSV), and equipment qualification to support operational excellence and regulatory requirements.
Develop, execute, and review Test Method Validations (TMV) to ensure testing methods are accurate, reliable, and fit for purpose.
Ensure compliance with GxP, GAMP, ISO 13485, and internal quality standards, while maintaining thorough documentation and supporting audits and inspections.
Provide technical expertise on manufacturing equipment and processes, supporting equipment lifecycle management, design transfer activities, and successful new product launches.
Responsibilities
Lead validation strategies and quality initiatives for new product introductions, technology implementations, process improvements, and manufacturing changes to ensure compliance and product quality.
Plan, execute, and review validation activities, including Process Validation (IQ, OQ, PQ), Computer System Validation (CSV), and equipment qualification to support operational excellence and regulatory requirements.
Develop, execute, and review Test Method Validations (TMV) to ensure testing methods are accurate, reliable, and fit for purpose.
Ensure compliance with GxP, GAMP, ISO 13485, and internal quality standards, while maintaining thorough documentation and supporting audits and inspections.
Provide technical expertise on manufacturing equipment and processes, supporting equipment lifecycle management, design transfer activities, and successful new product launches.
Requirements
Strong knowledge of GxP, GAMP, ISO 13485, and validation best practices.
Experience with Process Validation (IQ/OQ/PQ) and CSV activities.
Technical understanding of manufacturing processes and equipment.
Experience in medical device, pharmaceutical, or other regulated industries.
Knowledge of new product introduction (NPI), design transfer, and equipment lifecycle management is highly desirable.
Tech stack
GxPGAMPISO 13485
Benefits
Progressive employment conditions with long-term perspective
A responsible and varied job in a global company with a strong local presence
A high level of personal responsibility and independent work
A safe space for creative thinking and learning at the workplace
Bonus system, extra vacation days and many other benefits
