Dear Job Seekers,
Novartis is Hiring for:
Job Title: MS&T, Technical Manager
- Technical Interface to external supplier: Establish partnership with external suppliers with focus to ensure and improve product process capability, to keep the knowledge of process up to date and to maintain the product in constant state of validation.
- Support respective external suppliers with Science- and Risk-based approaches to ensure that product quality can be sustainably reproduced.
- Act as SPOC to maintain the oversight and knowledge for entire manufacturing process throughout the entire commercial lifecycle at given external suppliers.
- Ensure an accurate understanding of manufacturing process and influencing factors (i.e. CQAs, CMAs and CPP) to ensure product quality and process robustness at the commercialization site.
- Analyze product-specific manufacturing data from APQRs and other relevant sources where needed and agree on state of control. Assess impact of technical changes, assess technical feasibility and resolve scope / design of technical batches, challenge technical risk and business benefit of proposed technical changes.
- Contribute to the registration strategy and ensure alignment of (regulatory) timelines for technical changes, transfers, launches and/or major deviations. Lead / support root cause investigation of product and process failures.
- Effectively collaborate closely with external suppliers to initiate and lead/support product / process remediation / improvement activities, involving multi-functional teams and with clear interfaces to Quality, Operations, Engineering and Technical Development.
- Maintain Division and/or cross-division networks to share lessons learned and standard methodologies related with process and technologies.
- Responsible for the validation oversight and for maintaining the product in constant state of validation. Challenge defined control strategy based on CQA and where vital on CPP, CMA. Prior to validation and for defined improvement projects.
- Review respective Quality Risk Analysis (QRA) prior to validation for technical changes. Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters. Review validation protocol and report as appropriate.
- Provide all vital information to generate the validation documentation.
- Support Validation Lead and Experts to assess need and plan validations, assess revalidation need.
- Participate in external supplier / product evaluation and selection process.
Experience: 9+ years
Salary: As per the Company Standards