Job Description

Department DetailsRole Summary1 To manage the complete operations for DSP 1, DSP2 (Reaction area)
2 Production planning and control of operations to meet the business requirements in coordination with cross functional team
3 Coordination with PE/MSAT and development team for tech transfer
4 Coordination with cross functional team to implement the Operational excellence, Lean manufacturing concepts and Cost reduction measures
5 To ensure and implement safety practices at work place
6 Execution of process validation batches in line with validation master plan
7 Coordination with cross functional team to resolve the process related issues / Deviations/OOS/OOT and implement effective CAPA
8 To ensure adherence to EHS policies and procedures
9 To ensure that appropriate Qualifications and validations are done pertaining to DSP 1 operations
10 To ensure that the required initial and continuing training of production personnel is carried out and adapted according to the need
11 To ensure and monitor the compliance with the requirements of cGMP and global regulatory standards
12 To participate in management reviews of process performance, product quality and
the quality management system
13 Responsible for day to day operations towards the objectives of continuously improving the performance metrics
14 Responsible for infrastructure and resource planning
15 People development for team building and improvements in competencies of the team members1 To manage the complete operations for Buffer preparation area
2 Production planning and control of operations to meet the business requirements in coordination with cross functional team
3 Coordination with PE/MSAT and development team for tech transfer
4 Coordination with cross functional team to implement the Operational excellence, Lean manufacturing concepts and Cost reduction measures
5 To ensure and implement safety practices at work place
6 Execution of process validation batches in line with validation master plan
7 Coordination with cross functional team to resolve the process related issues / Deviations/OOS/OOT and implement effective CAPA
8 To ensure adherence to EHS policies and procedures
9 To ensure that appropriate Qualifications and validations are done pertaining to buffer preparation operations
10 To ensure that the required initial and continuing training of production personnel is carried out and adapted according to the need
11 To ensure and monitor the compliance with the requirements of cGMP and global regulatory standards
12 To participate in management reviews of process performance, product quality and
the quality management system
13 Responsible for day to day operations towards the objectives of continuously improving the performance metrics
14 Responsible for infrastructure and resource planning
15 People development for team building and improvements in competencies of the team membersKey Responsibilities1 To manage the complete operations for DSP 1, DSP2 (Reaction area)
2 Production planning and control of operations to meet the business requirements in coordination with cross functional team
3 Coordination with PE/MSAT and development team for tech transfer
4 Coordination with cross functional team to implement the Operational excellence, Lean manufacturing concepts and Cost reduction measures
5 To ensure and implement safety practices at work place
6 Execution of process validation batches in line with validation master plan
7 Coordination with cross functional team to resolve the process related issues / Deviations/OOS/OOT and implement effective CAPA
8 To ensure adherence to EHS policies and procedures
9 To ensure that appropriate Qualifications and validations are done pertaining to DSP 1 operations
10 To ensure that the required initial and continuing training of production personnel is carried out and adapted according to the need
11 To ensure and monitor the compliance with the requirements of cGMP and global regulatory standards
12 To participate in management reviews of process performance, product quality and
the quality management system
13 Responsible for day to day operations towards the objectives of continuously improving the performance metrics
14 Responsible for infrastructure and resource planning
15 People development for team building and improvements in competencies of the team members1 To manage the complete operations for Buffer preparation area
2 Production planning and control of operations to meet the business requirements in coordination with cross functional team
3 Coordination with PE/MSAT and development team for tech transfer
4 Coordination with cross functional team to implement the Operational excellence, Lean manufacturing concepts and Cost reduction measures
5 To ensure and implement safety practices at work place
6 Execution of process validation batches in line with validation master plan
7 Coordination with cross functional team to resolve the process related issues / Deviations/OOS/OOT and implement effective CAPA
8 To ensure adherence to EHS policies and procedures
9 To ensure that appropriate Qualifications and validations are done pertaining to buffer preparation operations
10 To ensure that the required initial and continuing training of production personnel is carried out and adapted according to the need
11 To ensure and monitor the compliance with the requirements of cGMP and global regulatory standards
12 To participate in management reviews of process performance, product quality and
the quality management system
13 Responsible for day to day operations towards the objectives of continuously improving the performance metrics
14 Responsible for infrastructure and resource planning
15 People development for team building and improvements in competencies of the team membersEducational QualificationsRequired Education Qualification: Bachelor in Biotechnology
Required Experience: 0 - 2 years

Biocon