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.
Principle Responsibilities:
- The Role holder is responsible for assuring compliance of quality systems in assigned areas and support as an Analytical Subject Matter expert.
- Review and approve the analytical-related protocols and reports submitted by the CMO/CTL against regulatory guidance’s for adequacy, accuracy, and completeness.
- Review and approval of Finished product, API, Excipients, Primary Packing Material specifications, and method of analysis.
- Review standard operating procedures/policies pertaining to quality assurance, analytical development, and research development and ensure SOPs are updated as per current practice through regular review.
- Participate in investigations arising out of deviation/ failures /OOS/incidents in R&D and from contractor site with applicable cross-functional team.
- Review the documents and data submitted to regulatory authorities for data adequacy, accuracy, and completeness.
Qualifications and Education Requirements
- Post-graduate in pharmacy with a good academic background.
- Industrial experience: 3-6 years in a reputed pharmaceutical organization with exposure in analytical quality assurance.
Physical & Mental Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Must be able to sit for long periods of time
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
- May occasionally climb stairs and/or ride elevators
- The employee must occasionally lift and/or move up to 25 pounds
- Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
- Other miscellaneous job duties as required
