Job opportunity at a brand-new ambitious Oncology API Unit designed to meet International regulatory standards. It holds objective of EU-GMP and USFDA accreditations in near future.
The company has high reputation for quality standard in addition to administration and Management excellence program.
The candidate stands to work and learn in a professionally managed, system-based environment with congenial work environment.
Qualifications:
• ./M. Sc. (Chemistry)
• Experience: 5 to 6 years’ experience in Oncology API manufacturing.
Responsibilities:
• Management and functions of API Pilot plant
• Support for technology transfer from Pilot plant to Production
• Training of personnel for GMP, GDP, Manufacturing processes In-process controls, communication and co-ordination with other functional departments.
• Production planning, scheduling and execution
• Maintenance of area, equipment and utilities
• Manpower planning, cost control and timely dispatches
• Management of entire production process
• Support to process validation, cleaning validation and utility validation activities
The candidate must have appropriate hands-on experience in production of synthetic and semi-synthetic Drug substances and safety aspects of cytotoxic oncology APIs.