13 Aug
|
Sandoz
|
Hyderabad
Job Description Summary
The Technical Expert – Global MS&T; (Sterile), based in the Capability Hub, provides specialized technical support and product stewardship for sterile/aseptic manufacturing processes at assigned Sandoz manufacturing sites and external suppliers (CMOs). The role ensures robust, compliant, and well-controlled sterile operations through hands-on support in equipment/utilities qualification, aseptic 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 sterile product supply and compliance.
Job Description
Position Purpose:
The Technical Expert – Global MS&T; (Sterile), based in the Capability Hub, provides specialized technical support and product stewardship for sterile/aseptic manufacturing processes at assigned Sandoz manufacturing.
Your Key Responsibilities:
Your responsibilities include, but not limited to
Technical Support & Product Stewardship (Sterile/Aseptic)
- Provide technical expertise to sterile manufacturing sites in areas such as aseptic process design, equipment capability, utilities readiness, and troubleshooting. Act as the technical steward for assigned sterile products/processes to ensure operations remain validated, controlled, and contamination‑free. Support sterile process performance verification (CPV), EM/aseptic data review, and improvement initiatives to enhance process robustness. Ensure sterile operations remain in a validated and compliant state per MS&T; expectations, regulatory guidelines (EU Annex 1), and contamination control principles. Contribute to sterile investigations and preparation of OPV reports, PPQ documentation, regulatory responses, and scale‑up/aseptic capability assessments.
Validation & Compliance
- Support process validation and cleaning validation activities for drug substance and drug product at assigne
📌 Technical Expert MS&T-Sterile (Hyderabad)
🏢 Sandoz
📍 Hyderabad