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.
- Solid 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

Professional 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 (Telangana)
🏢 Sandoz India
📍 Telangana