Technology Transfer Officer

We are looking for a meticulous Officer Technology Transfer to champion process validation and technology transfer activities at Synnat Pharma Private Limited. As a key member of our team, you will be instrumental in monitoring process validation batches, meticulously recording observed data, and identifying opportunities for process improvements within our API Manufacturing Industry. Your responsibilities will extend to collecting, updating, and correlating data to identify variations, contributing to the preparation of process validation documents such as Batch Manufacturing Records (BMRs), protocols, and reports.

This role demands a proactive individual capable of working in shifts and collaborating effectively with cross-functional teams. The ideal candidate will possess a strong foundation in chemical engineering principles and a keen eye for detail, ensuring adherence to quality standards and regulatory requirements. You will play a critical role in the seamless transfer of technology and the continuous improvement of our manufacturing processes, contributing directly to Synnat Pharma's commitment to global leadership in the API sector.

Job Details

• Industry:

  API Manufacturing Industry

• Department:

  Technology Transfer

• Role:

  Officer Technology Transfer

• Location:

  Visakhapatnam

• Experience:

  0 years

• Employment Type:

  Full-time

• Qualification:

  Bachelor's degree in Chemical Engineering or related field

Responsibilities

Process Validation and Monitoring

• Monitor process validation batches meticulously, ensuring adherence to established protocols and procedures.
  
• Record and document all observed data, both qualitative and quantitative, with accuracy and attention to detail.
  
• Identify deviations from expected results and report findings to the superior for further investigation.
  
• Collaborate with production and quality control teams to troubleshoot process-related issues during validation runs.
  
• Ensure compliance with all relevant regulatory requirements and internal quality standards throughout the validation process.
  
• Analyze process validation data to identify trends and areas for process optimization.
  

Data Collection and Analysis

• Collect data from various sources, including batch records, laboratory analyses, and process monitoring systems.
  
• Update and correlate data with previous data sets to identify variations and potential process inconsistencies.
  
• Analyze data to determine the root cause of process deviations and propose corrective actions.
  
• Prepare reports summarizing data analysis findings and recommendations for process improvements.
  
• Maintain accurate and complete records of all data collected and analyzed.
  
• Present data and findings to relevant stakeholders in a clear and concise manner.
  

Documentation and Reporting

• Prepare process validation documents, including Batch Manufacturing Records (BMRs), protocols, and reports, in accordance with established templates and guidelines.
  
• Ensure all documentation is accurate, complete, and compliant with regulatory requirements.
  
• Maintain a comprehensive library of process validation documents for easy access and retrieval.
  
• Assist in the preparation of regulatory submissions related to process validation.
  
• Contribute to the development and maintenance of standard operating procedures (SOPs) for process validation activities.
  
• Generate periodic reports on the status of process validation activities.
  

Technology Transfer Activities

• Participate in the transfer of technology from research and development to manufacturing.
  
• Assist in the development and implementation of technology transfer protocols.
  
• Ensure that all necessary documentation is prepared and maintained during the technology transfer process.
  
• Provide training and support to manufacturing personnel on new technologies and processes.
  
• Collaborate with cross-functional teams to ensure a smooth and efficient technology transfer process.
  
• Troubleshoot technical issues that may arise during technology transfer.
  

General Expectations and Past Experiences

• Bachelor's degree in Chemical Engineering or a related field is essential.
  
• Demonstrated ability to work effectively in a shift-based environment.
  
• Proven ability to meticulously monitor process validation batches and accurately record observed data.
  
• Strong understanding of existing processes and the ability to identify areas for improvement.
  
• Proficiency in collecting, updating, and correlating data to identify variations.
  
• Experience in preparing process validation documents such as BMRs, protocols, and reports.
  
• Excellent teamwork and collaboration skills to work effectively with cross-functional teams.