We are the established global leader in generic antibiotics, with +50 medicines serving more than 200 million patients per year. We have a leading global program to combat antimicrobial resistance (AMR), taking a balanced, cross-sector approach to combatting this unprecedented global health threat. Our goal is simple: to ensure patients continue to receive the medicine they need, when and where they need it.
Your responsibilities will include:
* Accountable to ensure that departments execute and maintain the VMP activities in their respective scope of responsibility, including, annual revalidation process and cleaning procedures.
* Ensure robust product stewardship for all products manufactured at the site, and end-to-end technical oversight of product manufacturing processes, at all stages of their commercial lifecycle.
* Support excellence in manufacturing through standard setting and technical capability development and deployment.
* Achieve the highest standards in identifying and addressing process issues.
* Support the identification and implementation of new technologies.
* Ensure development and deployment of highly specialist technical skills and knowledge to meet the needs of the site’s product portfolio and strategy.
* Work collaboratively with functional management in technical research and development organization and technical operations to ensure that ‘Maintenance of Business’ projects (ie quality/compliance improvements and savings projects) are identified, prioritized and delivered with excellence.
* Own site implementation of Principle 3 “Manufacturing Process Capability” Practices 6 – 10 including progress tracking and provision of site evidence documents.
* Co-own site implementation of Practice 11 together with Site Engineering Head.
* Ensure technical training of site MS&T population in line with Practice 5.
* Comply and ensure compliance with the Novartis code of conduct as well as Integrity codes operative in the company. Perform on-line and classroom training which are required.
* Support in establishing specifications for site products and raw materials.
* Supervise the compliance of SOP’s of the department.
* Integrate CI agenda into 5 years site strategy. Active participation in CI initiatives (e.g.: projects improvement portfolio and PRM) definition, implementation and follow up. Leading/sponsoring improvement projects and proactively involve OpEx for project and/or KPI deviations. Assure development of CI capabilities and involvement of the people under their responsibility.
What you'll bring to the role:
* MSc. in Science, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent experience. Ph.D. desirable.
* Sound experience in aseptic manufacturing technology.
* Fluent in English and in Spanish.
* Proven experience driving quality & compliance in an organization.
* Knowledge of adult learning theory and practice, knowledge of learning effectiveness evaluation methodologies (Kirkpatrick etc) and strong analytical skills.
* Comprehensive and demonstrated understanding of regulatory and internal compliance management frameworks, systems and requirements.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is (y)ours to shape!
Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Pioneering access for patients
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)
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