Major Accountabilities Scientific & Technical Expertise
• Apply advanced scientific knowledge in mutagenic impurities and N-nitrosamines.
• Perform complex risk assessments and develop mitigation/remediation strategies.
• Troubleshoot scientific challenges using analytical and problem-solving skills.
• Conduct scientific literature and information searches.
• Promote knowledge sharing within the organization. Execution & Delivery
• Independently manage and complete projects within agreed timelines and quality standards.
• Handle multiple activities simultaneously.
• Demonstrate initiative, accountability, and innovative thinking.
• Work proactively with minimal supervision. Compliance
• Ensure all activities comply with regulatory requirements.
• Follow applicable quality standards, SOPs, and guidelines. Collaboration & Communication
• Work in alignment with the Sandoz culture and values.
• Collaborate effectively with international cross-functional teams.
• Build and maintain strong stakeholder relationships.
• Communicate scientific findings clearly and effectively. Experience Minimum

Requirements:
• Minimum 6 years of relevant pharmaceutical industry experience; or
• Minimum 3 years of relevant experience with a PhD.
• Proven experience in assessing mutagenic impurities and/or nitrosamines within a pharmaceutical environment.



Technical Competencies
• Strong understanding of ICH M7 principles and regulatory expectations related to mutagenic impurities and nitrosamines.
• Experience performing impurity risk assessments and developing control strategies.
• Familiarity with pharmaceutical manufacturing processes, API synthesis, and impurity formation pathways.
• Strong scientific writing and documentation skills.
• Technical expertise in Organic Chemistry, API synthesis, and pharmaceutical manufacturing processes.
• Experience in nitrosamine, mutagenic impurity, and quality risk assessments.
• Strong regulatory compliance knowledge (ICH M7, FDA, EMA, MHRA requirements).
• Excellent scientific writing, analytical thinking, and data interpretation skills.
• Effective communication, project management, and cross-functional collaboration capabilities.
• Hands on experience using Sci finder, Reaxys, Chem draw and other literature searching tools Skills Skilled Skills
• Excellent analytical thinking, problem-solving, and decision-making abilities.
• Ability to work independently and manage multiple priorities effectively.
• Strong stakeholder management and communication skills.
• Demonstrated success working within global, cross-functional teams.
• Fluent in English, both written and spoken.

📌 Sr.Manager - Quality operations (India)
🏢 Sandoz India
📍 India