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 capabilities of sites/CMOs.
Provide dat

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