Process Expert
3 mesi fa
Summary Responsible for developing, implementing and managing the site performance qualifications and requalification of existing equipment and cycles as well as any new equipment. Responsible for developing, implementing and managing the site process validation, primary packaging validation, process performance qualification, cleaning validation and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities' expectations and related SOPs. Responsible for scale-up cold kits by developing and executing a validation strategy according to cGxP. Executing and managing equipment performance qualifications, requalification, periodic reviews and process, primary packaging, shipping and cleaning validation activities to meet cGMP requirements on time and quality to ensure that site validation programs are compliant with global regulatory expectations. Validation Expert - Support Product Steward in maintaining the process control strategy.
About the Role Major accountabilities: Stewardship, Launches/Transfer: Support Product Steward in maintaining the process control strategy. Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed). Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending. Participate in transfers and launches by aligning on the product validation approach. Provide technical expertise for pre-validation / validation strategy. Ensure equipment is in qualified state and qualified ranges are aligned to meet process parameters. Assess impact of technical changes, assess their technical feasibility and determine scope / design of technical batches, challenge technical risk and business benefit of technical changes proposed. Contribute to registration strategy and support registration activities providing experimental data obtained during the validation activities, which will be used to prepare the related registration documentation. Validation: Establish a qualification and requalification program (PQ) for the site and execute activities according to plan and defend to authorities. Perform equipment periodic reviews according to internal procedures. Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities. Overall responsibility for establishment, prioritization, execution and tracking of Validation Master Plan for process, cleaning, packaging validation and ongoing process verification (OPV). Ensure equipment is qualified and manufacturing and cleaning processes are validated; overview on site state of validation is maintained. Establish and monitor validation KPIs. Maintain all validation activities in an inspection ready status. Author validation protocols and reports. Establish local procedures & templates for respective validation documentation. Ensure that all Site validation activities are performed and are in line with the current AAA (or applicable) Novartis requirements and cGMP, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes. Support MS&T activities in ensuring that responsible departments execute and maintain the VMP activities. Partner with Engineering, IT, QC, AS&T to define the interfaces to equipment, utilities and system qualification, analytical method validation. Execute equipment qualification and requalification. Provide all necessary information to perform the validation documentation, align with stability experts and QC labs to organize the stability samples. Manufacturing Excellence: Contribute to efficiency improvement programs. Training: Own the Training Curriculum for own Profile and internal or external contributors. Languages: English. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? Learn more.
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Division: Operations
Business Unit: Innovative Medicines
Location: Italy
Site: Saluggia
Company / Legal Entity: IT58 (FCRS = IT058) AAA Italy Srl.
Functional Area: Technical Operations
Job Type: Full time
Employment Type: Regular
Shift Work: No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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