Analytical Documentation officer Full Time

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 preparation such as SOP, COA, ATP, Specification and Method of analysis.

Principle Responsibilities

• Preparation and upload of Standard operating procedures, Spec and MOA in DMS.
• Conducting training for good documentation practices.
• Archival of General analytical documents.
• Conducting SOP training whenever required.
• Notifying pharmacopeia updates to the analytical team and preparing the assessment report.
• Should have exposure in preparing the documents in electronic DMS and tracking of documents review and approval process.

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 preparation of key analytical documents. Understating Good Laboratory Practices and Good Document Practices.
• Should have exposure in electronic DMS systems.
• 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.