Analytical Reviewer

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

Brief team/department description:

• The analytical team at R&D is playing an important role in product development of various dosage forms. The analytical team involves different workflows like analytical method development, stability studies, involving method verifications at CMO/CTL and post filling activities.
• This role is with Azurity R&D Analytical Review team, which coordinates all product development team’s analytical documents review, cross functional documents review such as QA, PMO, WPS and tracking of analytical document closers, compliance with respect to GDP, data integrity and calibration of instruments.

Principle Responsibilities:

• Review of daily calibration records and Review of scheduled calibration records.
• Review of Analytical tests request related ROA, raw data, custom calculations, LNB, report and electronic review as applicable.
• Review of certificate of analysis of API, Excipients and FP.
• Review of protocol and reports or related documents (for e.g.: instrument /equipment qualification, analytical method validation / method verification / method transfer or etc.).
• Review of technical summary reports, wherever applicable
• Preparation and review of standard operating procedures wherever applicable.
• Should have the exposure on electronic review of raw data generated in Empower, Lab solutions, audit trails of the data executed using different software.
• Review of incidents, change control and CAPA documents applicable to Analytical R&D workflow
• Conducting training on data integrity, GDP and awareness program specific to analytical workflow wherever applicable.

Qualifications and Education Requirements

• Graduate / Postgraduate in Pharmacy or Science.
• minimum of 5 years of experience in pharmaceutical analytical R&D or QC comes under this category.
• Exposure in review of key analytical documents. Understating Good Laboratory Practices and Good Document Practices.
• Should be able to interpret the analytical data with respect to formulation matrix.
• Proficient in written and spoken English

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.