Analytical Reviewer
Azurity Pharmaceuticals is seeking an Analytical Reviewer to join our Research and Development (R&D) team in Hyderabad, India. As a privately held specialty pharmaceutical company, Azurity focuses on developing innovative products that address the needs of underserved patients across various therapeutic areas, including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets. The Analytical Reviewer will play a crucial role in ensuring the accuracy and compliance of analytical documentation within our R&D department.
In this role, the Analytical Reviewer will be responsible for reviewing daily and scheduled calibration records, analytical test requests, raw data, custom calculations, laboratory notebooks, reports, and electronic data as applicable. Additional duties include reviewing certificates of analysis for active pharmaceutical ingredients (APIs), excipients, and finished products, as well as protocols and reports related to instrument and equipment qualification, analytical method validation, method verification, and method transfer. The reviewer will also prepare and review standard operating procedures (SOPs) and conduct training sessions on data integrity and good documentation practices specific to analytical workflows.
The ideal candidate will possess a graduate or postgraduate degree in Pharmacy or Science, with a minimum of five years of experience in pharmaceutical analytical R&D or quality control. Proficiency in reviewing key analytical documents and a solid understanding of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) are essential. The candidate should be capable of interpreting analytical data concerning formulation matrices and be proficient in both written and spoken English.
Azurity Pharmaceuticals offers a collaborative and inclusive work environment, providing opportunities for professional growth and development. Employees are encouraged to engage in continuous learning and contribute to the company's mission of delivering high-quality medications to underserved patient populations.