Katalyst Healthcares and Life Sciences
Responsibilities :
- Lead projects in manufacturing process areas to achieve process efficiencies such as increase in process yield, quality improvements, cycle time/throughput, and cost reduction initiatives.
- Gather and analyse process data using statistical process control methodology.
- Develop action plan to increase process robustness, prevent product loss, and control quality impact. Participate in process performance monitoring such as Track & Trend.
- Responsible for providing technical support in the resolution of shop floor situations and executing assigned tasks as required by the operational area.
- Lead investigations by following a structure problem solving approach and employing sound, scientific principles when identifying root cause and developing recommendations related to product and process.
- Generate technical justification to support and/or document process deviations/investigations and determine impact in product quality, yield, and product registration.
- Part of cross-functional team responsible for implementation of site projects/initiatives (continuous improvement, cost reduction, capacity increase, etc.) that lead to process remediation.
- Project management of smaller team, short duration projects within larger projects.
- Responsibility may include project coordination, monitoring, reporting, meeting management, and team communication.
- Lead the implementation of process validation for operational changes, new raw materials, and introduction of new process/technology.
- Generate technical justification determining impact of change and protocols/reports/manufacturing documents that support its execution.
- Assist the execution of experimental, demonstration, and validation lots.
- Maintain up-to-date product process documentation and assure they are following applicable procedures and regulations.
- Writes justification memos and scientific reports of quality controls and manufacturing documents.
- Provide scientific and technical support during regulatory audits and agency inspections.
- Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of Client's EHS program.
- BS or MS in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical)
- 5-7 years of technical experience in Process/Manufacturing/Project Engineering or similar role.
- Technical knowledge in fundamentals of pharmaceutical liquid-solid dosage forms processing.
- Effective verbal and written communication skills in English.
- Manufacturing, Quality, Supply Chain, Operational Excellence, Engineering, EHS.