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Urgent! Specialist / Associate Manager - MS&T Job Opening In India, India – Now Hiring Confidential

Specialist / Associate Manager MS&T



Job description

  • The individual shall have a comprehensive understanding and experience of using Quality Risk management framework and shall possess excellent investigational report writing skills.
  • The individual shall have hands-on experience of using structured RCA (Root Cause Analysis) methodologies such as impact assessment, Fish bone diagram, 5 whys, Timeline & process mapping for investigation of deviations.
  • Experience in handling Investigations and Deviations related to Process (Upstream / Downstream), Product & Equipment
  • Understanding of core manufacturing unit operations such as sampling, monitoring, and continuous process support.
  • The individual shall have broad experience working in GxP environment and handling procedural requirements for HA audits.
  • The individual will also be responsible for offering technical and scientific expertise to address process-specific matters, ensuring compliance with cGMPs, SOPs (Standard Operating Procedures), and relevant guidelines and functional standards (such as HSE (Health, Safety and Environment) and NOSSCE).
  • Prior experience of handling internal and health authority audits and inspections is preferred
  • Ensure overall inspection readiness for area of responsibility -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable).
  • Certification in investigation handling - Root cause analysis (RCA) is preferred.

Essential Requirements:

  • Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams.

    Desirable MSc/MS.

    or equivalent experience.
  • Min 5 years of experience in MS&T, Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substance or drug products in Sterile/Large Molecules platform/facility
  • Minimum of 5 years of pharmaceutical process validation and cleaning validation.
  • Should be familiar and able to perform basic statistical evaluations using Minitab or other statistical analysis tools.
  • Proficient knowledge on deviation handling, incident investigations, root cause analysis, and CAPA management.
  • Knowledge of risk assessment and risk management programs.
  • Should be familiar with regulatory guidance on validation, product filing and post approval changes.
  • Basic knowledge of statistical analysis, results interpretation, and usage of statistical tools (Example: Minitab, Statistica etc.).
  • Good communication, presentation and interpersonal skills.

Desirable Requirements:

  • Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams.

    Desirable MSc/MS.

    or equivalent experience.


Skills Required
Root Cause Analysis, pharmaceutical manufacturing


Required Skill Profession

Business Operations Specialists



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