MS&T Technician II

Teva Global Business Services; Goa; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Teva Global Business Services seeks a knowledgeable professional to prepare and manage technical documentation for pharmaceutical operations. The role covers batch records, protocols, and technical reports, with end-to-end documentation for scale-up and new product launches.

The candidate will support Regulatory Affairs with technical submissions, ensure GMP compliance, and collaborate across cross-functional teams on investigations, CAPA, and change control while maintaining rigorous quality

Qualifications

• MS&T experience 1–5 years.
• Experience in new submissions, launches, scale-up & process validation documentation and execution.
• TrackWise, Veeva, Glorya & SAP handling.

Responsibilities

• Prepare technical documentation (batch records, protocols, technical reports).
• Execute scale-up, transfer, new product launches with end-to-end documentation compliance.
• Coordinate with cross-functional teams.
• Support Regulatory Affairs with technical documentation for submissions and variations.
• Ensure GMP, safety and regulatory compliance in operations.
• Handle investigations and change control, deviations, CAPA, OOS with root-cause analysis.

Skills

MS&T experience

Cross-functional coordination

Documentation and records

Tools

TrackWise

Veeva

Glorya

SAP

Job description

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.