10 Aug
|
Sandoz India
|
India
10 Aug
Sandoz India
India
Position Purpose
The Technical Expert – Global MS&T;, based in the Capability Hub, provides specialized technical support and product stewardship for assigned Sandoz manufacturing sites and external suppliers (CMOs). The role ensures robust, compliant, and well-controlled manufacturing processes through hands-on support in process validation, technical investigations, product transfers, and preparation of technical documentation. The position serves as a key technical interface across internal sites, external partners, Development (SDC), and ESO to enable reliable product supply and technical compliance.
Your Key Responsibilities
Your responsibilities include, but not limited to:
Technical Support & Product Stewardship: Provide technical expertise to assigned Sandoz manufacturing sites in areas such as process design, equipment understanding, process performance assessment, and troubleshooting. Act as the technical steward for assigned products/sites to ensure processes remain validated, controlled, and capable. Support continued process verification (CPV), data review,
and process improvement activities to enhance process robustness. Ensure assigned products remain in a validated and compliant state as per MS&T; and regulatory expectations. Contribute to investigations and prepare OPV reports, PPQ documentation, regulatory responses, and scale‑up proposals.
Validation & Compliance: Support process validation and cleaning validation activities for assigned sites and products. Review and approve validation protocols and reports to ensure scientific robustness and regulatory compliance. Ensure the availability and accuracy of required technical documentation prior to major technical activities, including technical changes at Sandoz sites and CMOs. Provide technical assessments and recommendations for deviations, change controls, CAPAs, and customer complaints.
Technical Interface & External Supplier Support: Act as a key technical contact between Sandoz sites, CMOs,
📌 Technical Expert- Global MS&T Capability Hub (India)
🏢 Sandoz India
📍 India