MS&T Assosiate

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Job Description Summary The MS&T Associate provides technical expertise and documentation support to Site MS&T across the product lifecycle, supporting feasibility studies, process validation and cleaning validation, SOPs, and lifecycle management activities. The role contributes to maintaining a continued state of validation and process robustness through science and risk based approaches. This position supports critical and strategic initiatives by developing risk assessments, QbD based design documents, and technical justifications, ensuring timely and compliant project execution across global manufacturing and external sites. The MS&T Associate ensures effective knowledge sharing and provides second line technical support to manufacturing and quality teams Job Description Position Purpose: The MS&T Associate provides technical expertise and documentation support to Site MS&T across the product lifecycle, supporting feasibility studies, process validation and cleaning validation, SOPs, and lifecycle management activities. The role contributes to maintaining a continued state of validation and process robustness through science and risk-based approaches. This position supports critical and strategic initiatives by developing risk assessments, QbD based design documents, and technical justifications, ensuring timely and compliant project execution across global manufacturing and external sites. The MS&T Associate ensures effective knowledge sharing and provides second line technical support to manufacturing and quality teams. Your Key Responsibilities: Your responsibilities include, but not limited to: Technical & Process Lifecycle Documentation Support: Support Site MS&T and Technical Experts by managing and maintaining comprehensive technical documentation for assigned products across the commercial lifecycle. Act as a central point of contact for MS&T documentation, ensuring accuracy, consistency, and traceability of product and process knowledge. Data Trending & Process Monitoring Documentation: Prepare and maintain documentation inputs for APQR, Ongoing Process Verification (OPV), and product state‑of‑control assessments. Ensure timely preparation, review coordination, approval, and archival of protocols, reports, risk assessments, and project‑related technical documents. Ensure process performance data and analyses are clearly documented and readily available for technical and regulatory reviews. Support collection, compilation, and documentation of process data, statistical trending, and analysis of critical and key process variables. Risk Management & QbD Documentation : Support preparation, updating, and lifecycle management of product‑specific Quality Risk Assessments (QRAs), covering IPCs, CQAs, CPPs, and CMAs. Compile and maintain QbD‑based design documents, control strategies, and risk assessment documentation for technical changes and improvement initiatives Validation & Lifecycle Documentation Compliance : Support maintenance of a continued state of validation by preparing, updating, and managing process, cleaning, and OPV documentation. Coordinate execution, review, approval, and closure of validation protocols and reports in collaboration with Validation, Quality, and Site MS&T. Coordinate with QC and stability functions to ensure documentation readiness for sample planning and validation activities. T echnical Change & Investigation Documentation Support: Support technical change activities by preparing impact assessment documentation, risk evaluations, and technical justification records. Support root‑cause investigations, CAPA documentation, and product or process improvement records under guidance of the Technical Steward or MS&T Lead. Launch, Transfer & Cross‑Site Documentation Support: Support product launches and transfers by compiling structured technical data packages and supporting documentation. Facilitate effective documentation‑based knowledge exchange across functions, global manufacturing sites, and external partner Operational Excellence & Inspection Readiness: Ensure sustained inspection readiness through compliant, complete, and timely MS&T documentation aligned with global and site requirements. Support manufacturing robustness, optimization, and OpEx initiatives through structured documentation and data compilation. What you'll bring to the role: Essential Requirements: BSc. in Pharmacy, B. Pharma, Pharmaceutical Technology, Chemistry or equivalent scientific degree.. Minimum 4-8 year experience in Process support, Documentation and Lab and Shopfloor experience of pharmaceutical manufacturing. Proven process understanding (Pharma, GMP, Regulatory aspects). Sound experience of data handling and applied statistics is a must. Why Sandoz? Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world's medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ coun

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