Scientist, Inhalation Reserach and Development-NC (Technical Review and Electronic Systems Support)

Division Overview

Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor and is a wholly owned subsidiary of Aurobindo Pharma Limited, a leading generic pharmaceutical company based in India. Headquartered in HITEC City, Hyderabad, India, founded in 1986 and becoming a public company in India in 1992.

Aurobindo Pharma USA, Inc. is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals to pharmacists and patients. Aurobindo Pharma USA, Inc. adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Aurobindo has business operations in more than 125 countries around the world. Aurobindo is a global pharmaceutical company with a broad portfolio of generic drugs that includes more than 180 product families and 450 individual product packages.

Aurobindo markets over 80% of the top 100 most prescribed products in the world. In past years, Aurobindo has received more ANDA approvals than any of our competitors. Aurobindo is now ranked 2nd among pharmaceutical companies based on Total Prescriptions Dispensed. (We are#27 in 2010)

Job Overview

Capable of performing technical review of laboratory experimentation against test methods, internal standard operating procedures, and cGMPs. Previous GMP laboratory experience and technical reviewer experience are required. Review experience within an electronic laboratory notebook system is preferred. Experience with management and qualification of electronic systems preferred. Should be able to read and understand SOPs, test methods, protocols and other governing documents to ensure that work conducted is in alignment and compliant.

Responsibilities

• Reviews experimental documentation for accuracy, completeness, and compliance with internal procedures.
• Reviews reports for accuracy and completeness
• Maintain the document review metrics to ensure that books are completed, submitted for review, reviewed, and closed to meet internal procedures and expectations.
• Provides coaching to less experienced analysts to improve compliance and throughput
• Support deplloyment of the electronic laboratory notebook system through training, validation script review, and validation protocols and reports.

Qualifications - Skills & Requirements

• GMP laboratory experience for execution and documentation of testing and technical review of documentation is required.
• Previous experience with reviewing software validation scripts and documents is preferred.
• Must be able to monitor for compliance with project timelines for completion of notebooks and interact effectively with management to secure resources needed to drive completion.
• Must be able to lead/mentor others on documentation and documentation review.
• Must possess excellent oral and written communication skills and be able to thrive in a team environment.

Education & Experience

• BS in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field plus 6 years combined laboratory and review experience. At least three years in a GMP environment.

Physical Requirements

OFFICE POSITION - While performing the duties of this job the employee is required to: • Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment • Specific vision abilities required by this job include close vision requirements due to computer work • Light to moderate lifting is required • Moderate noise (i.e. business office with computers, phone, and printers, light traffic). • Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
Additional Physical Requirements

No Additional Requirements


Blood/Fluid Exposure Risk

Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.