14 Sep
|
Rajasthan Antibiotics
|
Udaipur
14 Sep
Rajasthan Antibiotics
Udaipur
Company Description
Rajasthan Antibiotics Ltd. (RAL-Life) is a quick-growing integrated pharmaceutical company that began commercial production in 1991 and has since become one of India’s largest producers of sterile Active Pharmaceutical Ingredients (APIs). The company is recognized as the first in India to produce Ampicillin Sodium Sterile and has pioneered the manufacturing of sterile anti-ulcer drugs such as Omeprazole Sodium Sterile and Pantoprazole Sodium Sterile. Its products have gained worldwide acceptance, reflecting strong quality standards and regulatory compliance.
RAL-Life offers professionals the opportunity to work in a technologically advanced, growth-oriented environment focused on sterile API manufacturing and continuous innovation.
Role Description The GM Plant holds end-to-end technical ownership of our penem API operations at Udaipur. This is a hands-on leadership position with genuine authority over technical decisions, reporting directly to the Managing Director, and covering everything from process development through to regulatory approval and commercial supply.
Key Responsibilities
- Lead end-to-end technical operations for oral penem APIs,
with accountability for yield, purity and cycle time
- Own process development and optimisation across the penem portfolio
- Drive technology transfer through to validated commercial manufacture[C1]
- Oversee all technical departments: Production, Quality Assurance, Quality Control, Analytical
Development, Engineering and EHS
- Establish and maintain the site quality management system
- Prepare the site for US DMF and CEP filings
- Lead regulatory inspections and customer audits, including front-room participation
- Build, lead and mentor the technical team
Required Experience & Qualifications
- Experience: 15+ years in API manufacturing, including at least five years as a Plant Head, Technical
Lead or in a comparable leadership role
- Domain: Direct penem API experience is essential
- Regulatory: Front-room participation in inspections — USFDA, EDQM, MHRA, TGA or WHO-GMP
- Education: M.Sc. or Ph.D. in Organic or Process Chemistry, or B.Tech / M.Tech in Chemical Engineering
- Language: Professional English and working Hindi.
📌 GM Plant API (Penems) (Udaipur)
🏢 Rajasthan Antibiotics
📍 Udaipur