OC Specialities - Incharge - Tech Transfer & Operation Excellence (15-17 yrs)
Position : Incharge - Tech Transfer & Operation Excellence
Department : Technical Services
Reporting To : Head - Technical Services
Location : Solapur
Section : Tech Transfer & Ops. Excellence
Reported By : Engineer/s & Chemist
Brief Role :
- Responsible for smooth transfer of batches from lab scale to commercial batches at the shop floor and to ensure quality system compliance.; ensure compliance to all regulatory and customer guidelines; document, train, guide and support production team for effective operations. Responsible for providing leadership for Process Safety and deploying Operational Excellence initiatives for continuous process improvement efforts in the organization for higher operational efficiency.
Key Responsibilities :
- In consultation with PD, support transfer of products from PD to production.
- Ensure Monitoring of Pilot Batches and compilation of all executed batch process documents.
- Ensure the process of technology transfer is carried as per the established compliance norms - both from a regulatory and customer perspective.
- Coordinate with Quality Assurance department to check and approve all kinds of technology transfer documentation.
- Ensure maintenance of lists/ documents/ records for the function as per the defined norms.
- Provide guidelines and supervision of batch sizes, scale up trials and validation support of the analytical methods for different products being transferred, in line with cGMP, Quality Policy and EHS norms.
- Document and report completion of technology transfer data
- Develop policy, processes and Standard Operating Procedures (SOPs) with respect to Process Safety and Operations Excellence; ensure implementation of the same within the organization.
- Deploy Operational Excellence initiatives like Continuous Improvement Management System (CIMS), Lean Manufacturing, Six Sigma, Total Process Control (TPC) etc. across the organizational for improving the operational efficiency.
- Develop frameworks for identification of areas of improvement in business processes; develop improvement initiatives for improvement areas identified through continuous implementation of the process improvement framework.
- Develop, gather and analyze key organizational quality metrics and perform periodical reviews to evaluate trends and results and establish action plans to provide the necessary improvement at an operational level.
- Keep abreast of new developments in the areas of process safety and operational excellence globally; evaluate the feasibility of implementing new practices and norms within the organization, implement the same if found feasible.
- Keep track of changing statutory/regulatory requirements and customer requirements and expectations; ensure organization readiness to implement changes, if any in the existing systems and processes.
- Assist the Head- Technical Services in facilitating customer and regulatory audits.
- Ensure that all processes are in compliance with the standard regulatory instructions as well as customer specifications.
- Review and validate data generated through the process studies through implementing various tools like HAZOP studies, risk assessment studies etc.
- Document observations on process safety based on data analysis and interpretation; Liaise with R&D, Quality, Pilot / Production teams to make necessary changes in the process to address issues / potential hazard areas identified in through the process safety studies.
- Review existing production process on a periodic basis to evaluate the process safety of the same; recommend changes, if any in the processes
- Respond to and resolve customer queries, if any, around robustness of process safety measures in the commercial production process
- Participate in internal and external audits including customer audits and provide necessary data/ information, as may be required. Ensure that corrective actions are identified and implemented in based on audit observations.
- Ensure adherence to SOPs and applicable policies and guidelines in the departmental activity.
- Train all direct reports in the applicable Process Safety and Operational Excellence practices
- Monitor the performance of the team on a continuous basis to identify key performers.
- Mentor and coach subordinates to develop the team's capabilities.
- Provide guidance and support to team members, where required.
- Foster an environment of learning, excellence and team-work across the function.
Key Result Areas and Performance Indicators :
1. Method transfer
2. Operational Excellence Initiatives
3. Effective Process Safety
4. Timely & Accurate Documentation
5. Audit & compliance
6. Customer satisfaction (both internal and external)
7. People management and skill development
Behavioral Competencies :
- Problem Solving
- Open to Criticism
Job Specifications :
Education : BE/ ME/ MTech (Chemical)
- At least 15 years of relevant work experience
- At least 7 years- experience in tech transfer, operation excellence and process safety in chemical plant.