Novartis Pharma & Chemistry Specialist Job Opening – Apply Online

Novartis Pharma & Chemistry Specialist Job Opening – Apply Online

Novartis Pharma & Chemistry Specialist Job Opening – Apply Online. Interested and eligible applicants can check out all of the details on the same below:

Specialist – MS&T

Job ID: REQ-10026922

Date: Oct 22, 2024

Location: India

Summary

Job Purpose:

The Technical Specialist supports the 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 product oversight throughout the lifecycle. The scope includes all drug products bulk (DP), finished products (FP), and all chemical intermediates/APIs under Novartis’ responsibility. The Technical Specialist collects data from the Novartis Business Units and acts in accordance with legislation, internal rules, good practices, and business objectives.

About the Role

Major Accountabilities:

• Support validation programs, including process validation, ongoing process verification (OPV), risk assessment, cleaning validation, and ongoing cleaning verification for Novartis drug product and drug substance manufacturing sites.
• Create validation documentation, including process validation protocols/reports, risk assessment, ongoing process verification (OPV) plans/reports, and cleaning validation protocols/reports based on alignment with Site Validation Lead.
• Use monitoring tools such as OPV Monitor or Discoverant to perform OPV evaluations, assess process performance, and provide insights, recommendations, and conclusions to the site MS&T Lead/Product Steward.
• Create and review GxP documents, including SOPs, working procedures, trend reports, and technical investigations as needed.
• Support tasks related to technical changes and 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 and manage projects for smooth knowledge transfer activities from site/function to corporate Center.
• Act as the single point of contact for services delivered to sites/functions by the respective team, including the review of feedback and timely completion of identified actions.
• Coordinate with the Global MS&T team and IT team for ongoing data management, evaluation, and reporting in the OPV Monitor or Discoverant tool.
• Coordinate the preparation of documents in the correct formats (e.g. 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.
• Coordinate documentation review with site MS&T, QA, and QC, and Reg CMC where applicable.
• Obtain deviation reports from relevant systems to support validation and enable conclusions.
• Coordinate DI checks with the Data Integrity Manager where applicable.
• Coordinate inputs from respective functions (QA, QC, MS&T) to create validation documents and decide on the study strategy.
• Coordinate the execution of the study with respective functions, collect results, and create reports.

Others:

• Ensure compliance with Novartis internal quality standards, relevant regulatory requirements, filed product quality standards, and service level agreements.
• Implement and adhere to all instructions and requirements for safe work, environment protection, and property protection.
• Handle 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 other internal procedures and processes.
• Assist the department with any other ad hoc activities/requests to meet business requirements.
• Regularly communicate with partners and obtain feedback on services delivered.

Key Performance Indicators:

• Quality / Accuracy / Right First Time
• Timeliness
• Deviations / Escalations

Ideal Background / Requirements for the Role:

• Bachelor’s degree in Pharmacy, Pharmaceutical Technology, Chemical Engineering, Chemistry, or equivalent science streams (MSc/MS or equivalent experience desirable).
• Minimum 5 years of experience in MS&T, Quality Assurance, Regulatory, or in the manufacturing of pharmaceutical drug substances or drug products.
• Minimum 3 years of experience in pharmaceutical process validation and cleaning validation.
• Experience in pharmaceutical process validation protocol/report writing, cleaning validation protocol, and report writing, preferably in sterile manufacturing setups or biologics.
• Familiarity with performing basic statistical evaluations using Minitab or other statistical analysis tools.
• Basic knowledge of deviation handling, incident investigations, root cause analysis, and CAPA management.
• Knowledge of risk assessment and risk management programs.
• Familiarity with regulatory guidance on validation, product filing, and post-approval changes.
• Basic knowledge of statistical analysis, results interpretation, and usage of statistical tools (e.g., Minitab, Statistica).
• Strong communication, presentation, and interpersonal skills.
• Fluent in English (oral and written).

Link to Original Notification to apply

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