Quality Validation Engineer - Equipment Validation

• Full-time

With sales of €700m and 3,300 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built very long lasting, strong relationships with the leading global pharmaceutical companies globally by providing high quality development, industrialization and manufacturing services.

Nemera develops and manufactures its own IP product platforms but also offers also fully custom developments and contract manufacturing.

Nemera’s manufacturing sites are located in the US, France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon).

We have big ambitions at Nemera! We are growing our franchises and strengthening our capabilities.

The Quality Validation Engineer is responsible for planning, coordinating and managing through completion, assigned projects to ensure the development and production of products meets customer and internal quality deliverables. Coordinate and lead investigations regarding customer complaints. Work with Supply Chain management to evaluate and manage supplier performance. Duties and responsibilities are accomplished personally or through collaboration with other staff.

• Assists the Quality Manager in coordinating and executing objectives throughout the company in cooperation with other departments, to maximize product quality and operating system efficiency/effectiveness while minimizing cost
• Identify and coordinate resolution of system inefficiencies that contribute to increased quality costs.
• Coordinate and manage the execution of validations and creation of written protocols.
• Coordinate and manage the execution of change control activities.
• Assess results of Customer Complaint investigations and Corrective Actions for application, validity and conformance to FDA regulatory, QSR, ISO and Customer requirements.
• Utilize CAPA problem solving techniques to reduce internal and external failures, selects sound techniques (FMEA, Design of Experiments, Cause and Effect, Flow Charts, SPC) to solve problems effectively, and assess results for application, validity and conformance to specifications.
• Develop and analyze statistical data in relationship to assigned tasks to determine adequacy of present standards and establish proposed quality improvements, including analysis of current inspection methods and sample plans.
• Evaluate compliance using relevant information and individual judgment to determine whether events or processes comply with specifications, operating procedures or standards.
• Develop product specifications for existing products and assess existing specifications for accuracy and compliance.
• Plan, coordinate, and manage assigned Supplier Quality evaluations through scheduling and auditing of suppliers.
• Interact with suppliers and ensures mutual interpretation of specified requirements to make certain customer requirements and objectives are met.
• Support implementation and management of quality agreements with assigned suppliers.
• Plan, promote, perform and organize training activities for internal departments related to quality activities, including basic statistics, DOE, GR&R and Sample Plan designation.
• Interact with customers to assure mutual interpretation of specified requirements to ensure fulfilment of customer requirements and objectives are met.
• Assist the Quality Managers during customer audits and lead to final resolution any findings/observations resulting from the…