- Develop and implement process improvements to increase efficiency, reduce costs, and improve product quality in the pharmaceutical manufacturing process.
- Conduct HIRA (Hazard Identification and Risk Assessment) studies to identify potential hazards in processes and develop mitigation strategies.
- Collaborate with cross-functional teams to design, test, and validate new products or processes that meet regulatory requirements (GMP).
- Perform HAZOP (Hazard Operability Study) analysis to evaluate the feasibility of proposed changes to existing operations.
- - Knowledge and understanding of the Synthetic Organic chemistry , reaction flow diagrams, kinetics with 3 -5 years of industrial experience of various synthetic technique and process scale up. -Knowledge in plant operations,technology transfer.
- Knowledge of HIRA & HAZOP preparation.
- Capability of handelling pilot plant/plant activity
- Knowledge of Basic engineering design
- Desired Knowledge of plant operations,related softwares and quality systems, ICH guideline, GLP & GMP
- Very positive ability to interpret data, draw conclusions, and present results.
- Support Scale up and tech transfer. Discuss the defects in the process and suport in investigation as well as provide cost reduction process.
Job Requirements :
- 2-4 years of experience in Process Engineering or related field within the Pharmaceutical & Life Sciences industry.
- Strong understanding of GMP regulations and ICH-GCP guidelines.
- Experience with HIRA/HAZOP studies, risk assessments, and process optimization techniques.