Specialist / Associate Manager - MS&T

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