Job Title: Quality Expert, Data Analytics and Statistical Support
Location: Hyderabad, India (Hybrid)
***Relocation assistance is available for eligible candidates and their families, if needed.
Summary:
Be part of Lonza’s world-class Quality Systems and Strategy (QSS) team. As a Quality Data Specialist, you will play a vital role in ensuring the consistency and compliance of our manufacturing processes. By leveraging statistical tools and data science methodologies, you will provide the critical insights necessary for PQR and CPV reporting, ensuring that our life-saving products meet the highest standards of safety and quality.
What you will get
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- Exposure to advanced data systems and statistical methodologies in a global GxP environment.
- The opportunity to work with cross-functional teams to drive continuous improvement.
- The full list of our global benefits can also be found on https://www.lonza.com/careers/benefits
What you will do
- Generate and interpret control charts for Periodic Quality Review (PQR) and
- Continued Process Verification (CPV) reports across multiple departments and business units.
- Ensure the integrity of raw data within source systems, including Statistica, LIMS, and MES, to maintain accurate and compliant quality records.
- Communicate data excursions in a timely manner to relevant stakeholders to ensure business continuity and proactive risk management.
- Maintain and deliver consistent control charting for upcoming production campaigns, ensuring seamless transition and oversight between batches.
- Serve as the primary point of contact for technical inquiries related to statistics, data analysis, and complex data querying.
- Provide expert support for investigations by utilizing statistical tools and data science methodologies to identify root causes and trends.
- Collaborate with local functional leads to gather and validate data requirements across various business units.
What we are looking for
- Master’s degree in Life Sciences, Data Science, Information Technology (IT), Applied Statistics, Mathematics, or a related field, with a minimum of 5 years of experience working in a highly regulated, fast-paced environment.
- Strong SQL expertise with hands-on experience writing, optimizing, and maintaining queries to extract, transform, and analyze large datasets.
- Proficiency in statistical software (e.g., Statistica, Minitab) and familiarity with quality systems like LIMS and MES.
- Experience in a Quality or Manufacturing environment (GxP/GMP) is highly preferred.
- Strong analytical and problem-solving skills, with the ability to interpret complex datasets and identify significant trends.
- Basic understanding of statistical concepts, including probability distributions, hypothesis testing, and exploratory data analysis.
- Strong understanding of GMP and Data Integrity (DI) principles and their application to data management and analytics activities.
- Familiarity with ETL/ELT pipeline development and data integration across processes, manufacturing execution, and operational systems is an advantage.
- Experience with data lakes, cloud-based data platforms, and big data technologies is an advantage.
- Excellent communication skills, with the ability to translate technical statistical findings into actionable insights for non-technical stakeholders.
- High attention to detail and a steadfast commitment to data integrity and compliance standards.
- Ability to work independently while managing multiple priorities across different business units.
About Lonza
At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Skills Required
- Master's degree in a life sciences discipline
- At least 5 years of experience in a highly regulated environment
- Experience in a quality or manufacturing environment
- Experience with GxP/GMP environments
- Proficiency with statistical software such as Statistica or Minitab
- Familiarity with quality systems such as LIMS and MES
- Strong analytical and problem-solving skills
- Ability to interpret complex datasets and identify trends
- Excellent communication skills for translating statistical findings to non-technical stakeholders
- Strong attention to detail and commitment to data integrity and compliance
- Ability to work independently and manage multiple priorities across business units
What We Do
At Lonza, we enable A Healthier World by supporting our healthcare customers on the path to commercialization. Our community of 16,000 talented employees work across a global network of more than 30 sites to deliver for our customers across the pharma, biotech and nutrition markets.
