Stability Executive

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:

• Responsible for review of stability protocol / reports, evaluation of the data and preparation of its trend analysis.
• Responsible and support to ensure the Stability studies for all products in coordination with the contractor site.
• Responsible for preparation of stability schedule annually and monthly basis.
• Responsible for tracking stability pull out dates and communicate with contractors in timely manner testing and reporting.
• Preparation and review of standard operating procedures related to Quality Assurance and review of
• SOP related to other cross functional teams.
• Review the all QMS observed such as OOS/OOT/Change controls/Deviations/CAPA and investigation during stability testing.
• Positively interacts with internal stakeholders and external stakeholders such as contract manufacturing site/ contract testing labs.
• Support in implementation of compliance.
• Document management and archival.

Qualifications and Education Requirements

• B. Pharm or M.Sc. with a good academic background.
• Excellent written and verbal communication skills.
• Knowledge of all analytical techniques.
• Excellent skill in preparation of Presentation/Excel sheet and use of statistical tools
• Industrial experience:3-6 years in a reputed pharmaceutical organization with exposure in Stability studies, data review, stability trend analysis for all kinds of dosage forms.

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