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.
About the Role
Manager-R&D Quality Responsibilities:
The role holder is responsible for assuring Quality of product development and products technical release by assuring adequacy, accuracy and completeness of QMS documents.
Key Responsibilities
Quality Management System:
- Preparation and review of standard operating procedures related to Quality Assurance.
- Review of standard operating procedures related to formulation development, analytical development, regulatory affairs, information technology and research & development
- Review and approval of change controls, deviations out of specification and LIR etc.
- Responsible for reviewing the executed batch records, technical batch release to the market.
- Review and approval of risk management procedures pertaining to Failure Mode Effect Analysis
- Handling of stage gate process of product with respect to quality perspective.
- Providing inputs for quality metrics pertaining to contractors to the senior management on quarterly basis.
- Ensuring qualifications of contractors, vendors through vendor questionnaire, audits and Quality Technical Agreement
- Responsible to finalize quality agreements with contract organization and vendors, as applicable.
- Ensure completion of required trainings and perform only those activities for which training has been completed, if required.
- To ensure QMS documentation at all the time audit ready.
Design Control Support:
- Ensure product compliance with respect to the Quality system regulation requirements and 21 CFR 820 requirements.
- Monitoring current controls and highlighting if there are any residual risks in the product.
Regulatory Submission:
- Review and approval of protocols and reports pertaining to process validation, analytical method validation, method transfer, microbiology tests, study protocols such as photo stability, freeze thaw, stability study, optimization study, sampling, hold time study etc.
- Review and approval of specifications, reports related to technology transfer of the products.
- Review and approval of process validation protocols and reports.
- Review and provide comments related to "Client/ Customer feedback" for QMS documents such as change controls, deviations, out of specifications for contract organizations.
- Review of product development report (PDR) pertaining to products developed and manufactured for Azurity by contract development sites and, specifications, contract organization's documents.
- Ensure incoming materials used by contractors are from approved vendors.
- Auditing of Contractors/Internal and Handling of Audits:
- Auditing and certification of contract research organization, contract manufacturing organization, active pharmaceutical site pertaining to Azurity projects.
Required Skills and Experience
Experience minimum 12 to 15 years in the above role and responsibilities mentioned.
Good communication skills and clarity in the work performed.
Preferred Qualifications:
Master's or bachelor's degree in science.
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.
