Eugia is US-based independent specialty pharmaceutical company focused on generic sterile injectables, oncology, hormones, and ophthalmic medicines. Eugia has best-in-class, dedicated manufacturing and R&D capabilities to meet customer needs as they emerge. We are committed to consistently providing our customers with high quality specialty medicines.

 

Eugia’s mission is to make the process of buying specialty pharmaceutical products an experience customers look forward to, and our vision is to become synonymous with excellent customer service and continuously improve upon this excellence by being transparent, responsive, and consistent. We are expanding Eugia’s capabilities to include the manufacture of highly complex injectables to answer that need.

 

Eugia is the partner of choice to deliver on the promise of generic specialty pharmaceuticals.

 

This position is responsible for the technical review of raw data, qualification protocols, Certificate of Analyses, and other technical documents for the release of raw materials, finished products and stability monitoring. Functions will include supporting Laboratory investigations and writing technical reports for method transfers/verifications as it pertains to components, raw materials and finished pharmaceutical products. This position supports ensuring compliance with standard operating procedure and all regulatory requirements that may arise. This position is responsible for providing training to department employees as required stemming from deviations and/or laboratory investigations.

• Complete understanding of cGPM, GDP, 21CFR, ICH, USP and other guidance documents.
• Full review of analytical data and test results generated at QC.
• Review of analytical study protocols and reports.
• Review of SOPs, STPs, Specifications.
• Review of analytical data related to Raw materials, APIs, In-process, Finished Products.
• Review of Qualifications, Preventive Maintenances and Calibrations of QC lab instruments.
• Review of Analytical data packets for batch release, Certificate of Analysis.
• Review of stability data for finished product and stability trend report.
• Review of Audit trails for instrument software.
• Actively participate in laboratory investigations and draft reports, as necessary.
• Provide training to the QC lab chemists periodically for improvement in lab practices or to rectify recurring errors based on trend.
• Any other activities as deemed necessary by the management.

• Familiarity with commonly used QC laboratory instrument software; such as Empower-3 data collection system.
• Working knowledge of cGMP’s and regulatory requirements as they apply to pharmaceutical testing.
• Familiarity with compendial methods (USP/NF, EP, JP, BP etc.)
• Experience in investigation/deviation management and change control processes.
• Technical writing skill with experience related to QC laboratory.
• Proven written and verbal communication skills.

• B.S/MS degree in Chemistry/Pharmaceutical science.
• Minimum 5+ years’ experience in an QC/ARD (analytical chemistry) or technical review role in pharmaceutical industry, with an emphasis on raw data review.

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.

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

Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.