Careers

 The Manufacturing Operator will work other members of the production team to operate and maintain production equipment in accordance with Standard Operating Procedures. The Manufacturing Operator will also document  production and maintenance (batch records, room usage, cleaning and operation details) in corresponding logbooks as per Standard Operating Procedures and FDA cGMP guidelines. Experience in any processes like Granulation, Blending, Compression/Encapsulation and Coating is required

 Quality assurance directors are tasked with defining and promoting a quality mindset across an entire company. Directors are responsible for managing all QA functions, working with cross-departmental leadership to deliver high quality products on schedule. From hiring analysts and managers to leading incident investigations, QA directors establish and maintain a quality system to ensure a company’s facilities, equipment, personnel, methods, processes, and procedures conform to both internal guidelines and regulatory standards. .

Analyze FDA regulatory requirements for all pharmaceutical dosage forms, applying Analytical method development and validation, USP/NF, 21 CFRs FDA guidelines. Plan, prepare for, and manage all regulatory submissions, including CTD/eCTD (Electronic Common Technical Documents), NDA, and ANDA. Perform regulatory risk assessment and provide regulatory input to the executive team. Provide regulatory strategy for new pharmaceutical developments. Review and approve SOPs to regulatory authorities. Optimize and implement new processes in drug R&D and applications. Research and keep up to date on latest regulatory requirements and regulatory changes. Review and approve documents related to pharmaceutical product development, manufacturing, and testing. Train, develop, and mentor new and current members of the regulatory team;