Process Expert

Data: 12/07/2013

Novartis Italia ricerca: Process Expert (Job ID 122417BR).


Job Description
Responsible for Galenical and technical support of Manufacturing and Packaging processes for Novartis pharmOps Italy. This activity includes adherence to GMP requirements, Guidelines, SOPs, as well as respecting do-the laws, policies and procedures on HSE, with attention to the protection of company assets and compliance with the Code of Conduct Design and Lead process validations, re validations and Improvements. Write clear, concise protocols that comply with the site SOPs. Provide support to the manufacturing floor to ensure protocols are executed as intended. Write clear, concise, thorough process/packaging validation reports. Execute process improvements, scale-up, and justification projects. Ensure that process justification batches generate sufficient process knowledge by thoroughly testing critical variables. Support Packaging Engineer on introduction, Change / Optimization of packaging configurations for pharmaceutical products Ensure that technical specifications for process material are always current. Support Packaging Engineer on ensuring that technical specifications for process material are always current. Control and design raw material optimisation projects. Provide fundamental knowledge of function and properties of excipients and APIs. Ensure thorough physical and chemical characterization as needed to justify reducing validation costs, and ensure raw material changes are made without affecting product quality. Lead product and process related critical investigations. Use scientific and statistical knowledge to analyze data to provide process insight, and to identify root causes of product and process failures. Provide scientific expertise and Education on assigned products. Be highly knowledgeable of product and process trends via ownership and usage of APR-PQR analysis process technology innovations. Be a resource to other departments for product and process knowledge. Lead team member technical project teams. Be a motivator of members of other team members to meet commitments. Communicate accomplishments and use timeline to measure progress. Provide training for assigned new processes and products.

Minimum requirements
• BSc. In Science, Pharmacy or Chemical Engineering.
• Extended technical knowledge in area of own expertise.
• Good knowledge of English proven.
• Minimum 5 years experiences in pharmaceutical formulation, process development, or manufacturing technology.
• Strong Statistical background, IQP Silver certification ( or green Belt equivalent) statistic level. Experience in DoE and Gage R&R wpuld be preferable.
• Experience in the packaging technology for pharmaceutical products would be preferable.
• Fundamental understanding of Standard pharmaceutical analytical testing.

Division: Pharma.

Business Unit: Global Technical Operations.

Country: Italy.

Work Location: Torre Annunziata.

Company/Legal Entity: Novartis Farma IT.

Functional Area: Production.

Job Type: Full Time.

Employment: Type Regular.


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