Specialist / Associate Manager - MS&T

4 weeks ago


Hyderabad, Telangana, India Sandoz Full time
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.
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