Your Key Responsibilities
Your responsibilities include, but not limited to:
Key Responsibilities
- Technical Support to Internal Sites and CMOs Act as Technical Expert for assigned internal manufacturing sites or CMOs, ensuring process capability and maintaining products in a validated state.
- Apply science- and risk-based approaches to ensure sustainable product quality.
- Ensure availability of all relevant technical documentation (protocols, reports, risk assessments, concept papers, scientific justifications) ahead of planned site activities.

Product & Technical Stewardship
- Maintain oversight and deep understanding of the entire manufacturing process across the product lifecycle.
- Identify and monitor CQAs, CMAs, and CPPs to ensure process robustness and product quality.
- Analyze manufacturing data (OPV, CPV, APQR) to assess state of control and recommend improvements.
- Evaluate technical changes, assess feasibility, and define scope/design of technical batches.
- Contribute to registration strategy and align regulatory timelines for changes, transfers, launches,



and deviations.
- Lead/support root cause investigations for product/process failures and drive remediation/improvement initiatives.
- Collaborate cross-functionally with Quality, Operations, Engineering, and Development teams.
- Share best practices and lessons learned across divisions and sites.

Validation Support
- Define and implement validation strategies and supporting documentation.
- Maintain validation oversight and ensure products remain in a validated state.
- Review QRAs and challenge control strategies based on CQAs, CPPs, and CMAs.
- Ensure technical batches generate sufficient process knowledge.
- Support creation and review of validation protocols and reports.
- Contribute to revalidation planning and documentation.

Launch & Transfer Support
- Participate in supplier/product evaluation and selection processes.
- Gather and document technical information on manufacturing capabil

📌 Technical Expert MS&T (Telangana)
🏢 Sandoz India
📍 Telangana