Job Description

Department DetailsRole Summary1. Continuous monitoring and review of the downstream part of the DS manufacturing process at B3 Site. Analyze, anticipate, respond to, and resolve process issues that arise during manufacturing.
2. Performing continued process verification to ensure that the process is under validated state of controls and it delivers consistent product quality and yield consistently.
3. Evaluate downstream manufacturing process and institute process improvement/optimization, scale-up, tech transfer, debottlenecking and productivity and throughput increase, COGS reduction initiatives and evaluation and implementation of new technologies wherever applicable.
4. Effectively work and communicate with team, CFTs and partners for planning and execution of downstream process improvement activities and formulation/ review/ revision of procedural controls and procedures in the processes and its implementation in the manufacturing process.
5. Authoring/ reviewing of process/ QMS/ process part of regulatory filing documents. Participate and lead in cross-functional root cause analysis and problem solving on technical process issues (e.g., recurring deviations, quality-investigations, and CAPA).
6. Follow and adhere to rules, regulations and procedures, data integrity and compliance in performing the assigned activities.
7. To perform responsibilities of Departmental Training Coordinator such as management and effectiveness of trainings in MSAT group.Key Responsibilities1. Continuous monitoring and review of the downstream part of the DS manufacturing process at B3 Site. Analyze, anticipate, respond to, and resolve process issues that arise during manufacturing.
2. Performing continued process verification to ensure that the process is under validated state of controls and it delivers consistent product quality and yield consistently.
3. Evaluate downstream manufacturing process and institute process improvement/optimization, scale-up, tech transfer, debottlenecking and productivity and throughput increase, COGS reduction initiatives and evaluation and implementation of new technologies wherever applicable.
4. Effectively work and communicate with team, CFTs and partners for planning and execution of downstream process improvement activities and formulation/ review/ revision of procedural controls and procedures in the processes and its implementation in the manufacturing process.
5. Authoring/ reviewing of process/ QMS/ process part of regulatory filing documents. Participate and lead in cross-functional root cause analysis and problem solving on technical process issues (e.g., recurring deviations, quality-investigations, and CAPA).
6. Follow and adhere to rules, regulations and procedures, data integrity and compliance in performing the assigned activities.
7. To perform responsibilities of Departmental Training Coordinator such as management and effectiveness of trainings in MSAT group.Educational QualificationsRequired Education Qualification: B.Tech
Required Experience: 3 - 6 years

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