Global Lead Statistics & Data
Location
Andhra Pradesh | India
Job description
About the role
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!
Job Purpose:
Provide leadership on the development and deployment of statistics strategy for the manufacturing network. Provide excellence in statistical support to the platform / sites and within the global network to drive the application of advanced and pioneering statistical principles, tools and methodologies to improve process understanding, quality and compliance of the products, efficiency and capability of the processes and profitability of the organization. Interact with key collaborator groups such as Operational Excellence to develop and deploy statistical applications.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
1. Stewardship:
Support definition of Internal Release Limits (IRL) and Out-of-Expectation (OOE) limits.
Implementation Real Time Data Analytic Tools to help expedite analyzing of generated data and implement efficient procesc Controls & CAPA’s as needed to improve efficiencies of Mfg processes.
2. Validation:
Develop standard processes roadmap and harmonize application for STO / platform, in alignment with corporate and regulatory guidelines.
Perform statistical analysis of process validation data for demonstrating validity and equivalence.
Plan and evaluate Design of Experiments (DoEs) in the frame of the Sandoz Quality by Design (QbD) validation strategy.
Perform trending analysis in the frame of Ongoing Process Verification (OPV):
Implement and apply Statistical Process Control principles, e.g. control charts, and other pattern recognition techniques. Chip in to the development of fit-for-purpose platform to align with long term OPV requirements.
Support the standardization and automated statistical evaluation of APQRs.
Support the introduction of Process Analytical Technology (PAT) by facilitating and enabling (multivariate) process monitoring and control principles, e.g. by Multivariate Data Analysis (MVDA).
Support development and deployment of new requirements, such as definition of Internal Release Limits (IRL), in line with corporate and regulatory expectation.
3. Training:
Lead the Training Curriculum for own Job Profile.
Develop, deploy and maintain training for statistics and PAT for MS&T employees and other functions on global / platform / site level.
Role Requirements
What you’ll bring to the role:
Essential Req·
1. Education (minimum/desirable): BSc. in Pharmacy, Pharmaceutical Technology, Biology, Chemistry or equivalent scientific degree.
Desirable BSc, MSc. or B Tech.
2. Languages: Fluent in English & Local Language of the respective Country.
3. Relevant Experiences: Minimum 5 years of experience in pharmaceutical (chemical) manufacturing.
Experience in a global/matrix environment in the pharmaceutical industry
Comprehensive know how in pharmaceutical (chemical) technology
Project Management experience
Sound experience of data handling and applied statistics
You’ll receive:
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
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!
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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