MS&T Technician II

Role & responsibilities

• Preparation of Technical documentation such as batch records, protocols, and technical reports.
• Preparation, and execution of scaleup batches, transfer batches, new product launches, and validation batches with endtoend documentation compliance.
• Coordination with crossfunctional teams.
• Support to the Regulatory Affairs team by providing technical documentation and responses required for regulatory submissions and variations.
• Ensuring strict compliance with GMP guidelines, safety procedures, and regulatory requirements in all operational activities.
• Handson experience TrackWise/Veeva .
• Managing Change Control, Deviations, Investigations, CAPA, and OutofSpecification (OOS) handling, including root cause analysis and closure.
• Mainly Responsible for New product projects and process validation and Market support program on the shop floor. 
  Risk assessment of process parameters and material attributes with combination of prior knowledge of experiments to establish a design space or other representation of process understanding.
• Identify the critical process parameters and input material attributes that must be controlled to achieve quality attributes of the final product.
• Utilization of Knowledge of unit operations, analytical and statistics for process validation activity.
• Handling of investigations and quality system documents.

Preferred candidate profile

• Experience in MS&T about 1-5 years.
• Experience in: New submissions & launches  
  Scale up & process validation documentation and execution.
  Handling of Trackwise, Veeva, Glorya & SAP.