Senior Executive, R&D Quality Assurance
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:
This role supports that R&D Quality Assurance organization with know-how in GMP, Quality Control, Analytical Development, and management of stability programs.
Principle Responsibilities:
Quality Assurance Oversight of Internal R&D Laboratory:
- Provide Quality Assurance oversight to the laboratory, manufacturing, and analytical control activities of R&D Laboratory in Hyderabad
- Oversee laboratory change controls, investigation reports and incidents for their timely closure
- Oversee of Stability Chamber’s data logs and reports review.
- Issuance of laboratory Notebooks (LNBs) and Usage Logs and retrieval/archival of documents (LNBs, Usage Logs, calibration documents, raw data files, qualification documents etc).
- Approval of specifications and methods of analysis of Active pharmaceutical Ingredients, Finished Products, Excipients, Primary Packing Material used in R&D laboratory.
Analytical Quality Assurance with external CMOs/Labs:
- Quality oversight of analytical method transfers from the R&D laboratory to the GMP vendor for pipeline products, and between two GMP vendors for already approved products.
- Quality oversight of analytical data of registration/validation batches aimed at supporting new marketing authorization application.
- Review and approve analytical method transfer, analytical method verifications, analytical method validation, and CMC documentation (Microbiology and Chemical tests) including pre-transfer support to Quality Control of the R&D laboratory.
- In collaboration with R&D Quality Operations, conduct batch review and technical release of registration batches (no market release) and review/approve its related documentation such as OOSs, change control, CAPA.
- Ad-hoc support of the commercial Quality Operations Team with investigations related to significant out-of-specifications and product complaints of commercial products.
- Review and approval analytical CMC documentation prior to regulatory filing related to new submissions and to already approved products (i.e. post-approval changes).
- Oversee the Pilot bio batch manufacturing and batch clearance for Bio Availability/Bio Bioequivalence studies.
- Support the qualification of GMP vendors located in India, with local auditing.
- Oversight of R&D stability studies enabling new drug applications.
- Approval of Master equipment list and Master calibration schedule in R&D.
Qualifications and Education Requirements
- 5+ years of experience in Quality Assurance or Quality Control in Pharmaceutical Companies
- Bachelor of Science in Chemistry or Pharmaceutical Sciences.
- Experience with Analytical Methods development/validation is necessary.
- Knowledge of ICH Stability studies
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.
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