Senior Technology Transfer Officer

Role & responsibilities

Process Validation and Monitoring

1. Monitor process validation batches meticulously, ensuring adherence to established protocols and regulatory requirements.

2. Record observed data accurately and comprehensively, maintaining detailed records of all validation activities.

3. Identify areas for process improvements based on observed data and analysis, proposing solutions to enhance efficiency and product quality.

4. Prepare comprehensive process validation documents, including Batch Manufacturing Records (BMRs), protocols, and reports, ensuring accuracy and completeness.

5. Ensure all process validation activities comply with cGMP guidelines and relevant regulatory standards.

6. Collaborate with cross-functional teams, including manufacturing, quality control, and R&D, to ensure seamless execution of validation activities.

Manufacturing Process Analysis and Documentation

1. Maintain accurate and up-to-date documentation of all manufacturing processes, ensuring compliance with internal procedures and regulatory requirements.

2. Record and report data on an immediate basis, communicating any deviations or anomalies to the superior promptly.

3. Observe manufacturing operations closely, identifying criticalities and potential risks to product quality and process efficiency.

4. Develop protocols for monitoring the manufacturing process at both R&D scale and plant scale, capturing critical data points for analysis.

5. Prepare detailed manufacturing process flowcharts, mapping equipment and process steps to ensure clarity and consistency.

6. Understand existing manufacturing processes thoroughly, identifying critical parameters and potential areas for optimization.

Data Collection and Analysis

1. Maintain a comprehensive database of process data, ensuring data accessibility and integrity for future analysis.

2. Utilize statistical tools and techniques to analyze data and identify statistically significant trends.

3. Prepare detailed reports summarizing data analysis findings, communicating key insights to relevant stakeholders.

4. Analyze data to identify potential causes of variations, proposing solutions to mitigate risks and enhance process robustness.

5. Update and correlate data with previous data sets, identifying trends and variations to inform process improvements.

6. Collect data (qualitative and quantitative) from manufacturing processes, ensuring data integrity and accuracy.

Chemical Engineering and Technical Support

1. Stay up-to-date with the latest advancements in pharmaceutical technology and manufacturing processes, applying knowledge to improve internal operations.

2. Contribute to the development of standard operating procedures (SOPs) and other technical documents, ensuring clarity and accuracy.

3. Participate in equipment mapping exercises, ensuring accurate documentation of equipment configurations and process connections.

4. Assist in the development and implementation of process improvements, leveraging chemical engineering principles to enhance efficiency and product quality.

5. Provide technical support to manufacturing personnel, addressing process-related issues and providing guidance on best practices.

6. Perform basic chemical engineering calculations as needed, supporting process optimization and troubleshooting efforts.

Technology Transfer Activities

1. Contribute to the development of technology transfer strategies and best practices.

2. Support the training of manufacturing personnel on new processes and technologies.

3. Ensure that all technology transfer activities comply with regulatory requirements and internal procedures.

4. Collaborate with cross-functional teams to address any technical challenges during the technology transfer process.

5. Assist in the preparation of technology transfer documentation, including process descriptions, equipment specifications, and validation reports.

6. Participate in technology transfer activities, ensuring the smooth and efficient transfer of manufacturing processes from R&D to commercial production.