Specialist - MS&T

Major Accountabilities

Key Performance Indicators (Indicate how performance for this role will be measured)
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. Desirable MSc/MS. or equivalent experience.
Min 5 years of experience in MST, Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substance or drug products.
Minimum of 3 years of pharmaceutical process validation and cleaning validation.
Should have the experience in pharmaceutical process validation protocol/report writing, cleaning validation protocol and report writing, preferably in sterile manufacturing setups, biologics.
Should be familiar and able to perform basic statistical evaluations using Minitab or other statistical analysis tools.
Basic 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.
Fluent in English (oral and written).