Major accountabilities:

Scientific& Technical Expertise

- Apply advanced scientific knowledge inmutagenic 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 robust stakeholder relationships.

- Communicate scientific findings clearly and effectively.

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Minimum Requirements:

Experience

- 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:

Qualified 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
📍 Telangana