Stability Manager

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 managing the stability program in coordination with contract organizations.
• Responsible for approving stability schedule on an annual and monthly basis.
• Responsible for tracking stability pull out dates and communicate with contractors in a timely manner to ensure testing and reporting perform within due period.
• Reviewing stability protocol / reports, evaluation of the data and its trend analysis after receiving stability data from the contractor site.
• Responsible for escalating any delay in withdrawal/ identifying any adverse trend in the stability data to senior management.
• Responsible for conducting the investigations for stability failures, delays and other issues.
• Preparation and review of standard operating procedures related to Quality Assurance and review of SOP related to other cross functional teams in the areas of stability and analytical compliance.
• Participates in all QMS activities such as OOS/OOT/Change controls/Deviations/CAPA and investigation.
• Positively interacts with internal stakeholders and external stakeholders such as contract manufacturing site/ contract testing labs.
• Ensure SOPs are updated as per current practices through regular review.
  
  

Qualifications And Education Requirements

• M. Pharm or M.Sc. with a good academic background.
• Excellent written and verbal communication skills.
• Excellent skill in preparation of Presentation/ Excel sheet and use of statistical tools.
• Excellent knowledge of all analytical techniques.
• Industrial experience:10-15 years in a reputed pharmaceutical organization with experience in analytical compliance, Stability studies, data review, trend analysis for all kinds of dosage forms.
  
  

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.