Summary

Job Purpose:
The Technical specialist supports MS&T team on sites by collecting data, reviewing or writing technical documents related to validation (e.g. process validation, ongoing process verification, cleaning validation, packaging), APR PQR, technical files, product risk assessment procedures and maintaining a product oversight throughout the lifecycle. The scope includes all drug products bulk (DP), finished products (FP) and all chemical intermediates/APIs under Novartis responsibility. For that purpose, technical specialist collects data from the Novartis Business Units, act in accordance with legislation, internal rules, good practices and business objectives.

About the Role

Major Accountabilities

• • Support Validation program including process validation, ongoing process verification (OPV), risk assessment, cleaning validation, ongoing cleaning verification for Novartis drug product and drug substance manufacturing sites.
• • Create validation documentation including process validation protocol/reports, risk assessment, ongoing process verification (OPV) plans/ reports, cleaning validation protocol/reports based on alignment with Site Validation Lead.
• • Using monitoring tool such as OPV Monitor or Discoverant perform, OPV evaluations, assess process performance and provide insight, recommendation, and conclusion to the site MS&T Lead/Product Steward.
• • Create and review GxP documents including SOPs, working procedures, trend reports, and technical investigations, as and when needed.
• • Support tasks related to technical changes, incident investigations for the product and process.
• • Provide active support during internal and external audits by collecting and presenting the requested process/ data and reports.
• • Coordinate & manage project for a smooth knowledge transfer activity from site/ function to corporate Center.
• • Act as single point of contact for the services delivered to sites/ functions by the respective team, including the review of feedback and timely completion of identified actions.
• • Coordinates with Global MS&T team, IT team for the ongoing data management, evaluation and reporting in the OPV Monitor OR Discoverant tool.
• • Coordination of documents preparation in the right formats (eg. Novstyle for Subway, ESOPS etc) and ensure timely review and approval of the documents.
• • Ensure services are delivered on time and in line with partner and Novartis MS&T requirements.
• • Coordinates documentation review with the site MS&T, QA, and QC, also Reg CMC where applicable.
• • Obtains deviation reports from relevant systems in support to validation to enable conclusions.
• • Coordinates and owns DI check with Data integrity manager where applicable.
• • Coordinates inputs from respective functions (QA, QC, MS&T), to create the validation documents and decide on the study strategy.
• • Coordinates the execution of the study with respective functions. Collects results and creates reports.
• Others:
• • Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements, filed product quality standards and service level agreements.
• • Implementation of and adherence to all the instructions and requirements for safe work, environment protection, and property protection.
• Other tasks determined during the annual objectives setting process and by KPIs.
  • Comply with internal functional requirements such as KPI reporting, ticket management tools and any other internal procedures and processes.
• Assist the department on any other ad hoc activities/ requests to meet the business requirements
• Regularly communicate with partners and obtain feedback on services delivered.