Quality Expert, Data Analytics and Statistical Support

Lonza; Hyderabad; Hybrid; Confidential; Full time

Job summary

Lonza Hyderabad is seeking a Quality Expert, Data Analytics and Statistical Support to drive data integrity and analysis across GxP processes. You will generate control charts for PQR and CPV, ensure data quality in Statistica, LIMS and MES, and collaborate with cross-functional teams to enable proactive risk management.

The role emphasizes statistical rigor, clear communication of insights to non-technical stakeholders, and supporting investigations using data-driven methods in a hybrid work

Qualifications

• Masters degree in Life sciences with 5+ years in regulated environment.
• Experience in Quality or Manufacturing (GxP/GMP).
• Proficiency in Statistica and Minitab.
• Familiarity with LIMS and MES.
• Strong analytical and problem-solving skills.
• Excellent communication and ability to translate stats for non-technical stakeholders.
• High attention to detail and data integrity.
• Ability to manage multiple priorities independently.

Responsibilities

• Generate and interpret control charts for PQR and CPV reports across departments.
• Maintain data integrity in Statistica, LIMS, and MES.
• Communicate data excursions to stakeholders to ensure continuity and risk management.
• Deliver consistent control charting for upcoming production campaigns.
• Act as primary contact for statistics inquiries and data queries.
• Provide investigations support using statistical tools and data science methods.
• Collaborate with functional leads to validate data requirements across units.

Skills

Statistical analysis

Data interpretation

Quality systems

GxP experience

Communication skills

Attention to detail

Education

MSc Life Sciences

Tools

Statistica

Minitab

LIMS

MES

Job description

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

• Masters degree in Life sciences background with a minimum of 5 year’s experience working in a highly regulated, fast-pased environment.
• Experience in a Quality or Manufacturing environment (GxP/GMP) is highly preferred.
• Proficiency in statistical software (e.g., Statistica, Minitab) and familiarity with quality systems like LIMS and MES.
• Strong analytical and problem-solving skills, with the ability to interpret complex datasets and identify significant trends.
• 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.