Executive, R&D Development QA (DQA) / Documentation

You will be responsible for reviewing R&D developmental data of ARD and PD including Method Development Reports, Method Validation Reports, Characterization Reports, Product Development Report, and Study Reports to ensure accuracy, data integrity, and compliance with systems, procedures, and regulatory requirements. Additionally, you will review Technology Transfer documents such as Method Transfer protocol/Reports, Master Formula Records, Master Packaging Record, Stability Study protocol, Specifications, and MOAs. Conducting routine laboratory rounds to ensure compliance with Good Laboratory Practices will be part of your responsibilities. You will also handle Change Controls, Deviations, Incidents, and Laboratory Assessment Reports. Preparing and reviewing SOPs, conducting SOP training, and providing training on Good Laboratory Practices to R&D personnel are also key tasks. Management of development stability samples, including protocol review, sample charging, stability calendar updation, and sample withdrawal, will fall under your purview. Other duties include handling the receipt, issuance, and management of RLDs and Exhibit batch samples, as well as issuing R&D documents like LNBs, Forms, and Logbooks for routine use. You will be responsible for maintaining the Document Archival room of R&D, issuing archived documents upon request, and managing the receipt, storage, issuance, and management of Working Standards, Reference Standards, Impurity standards, and Chromatographic columns. Additionally, you will review and approve Instrument/Equipment Qualification and calibration records. Your skills should include expertise in Quality Management systems, Good Laboratory Practices, Analytical Method Development & Validation review, Documentation Control, and Stability Studies. Intermediate proficiency is required in Product Development Report Review, Internal Quality Audits, and Review of Specification and MoAs. In addition, you should have a basic understanding of Training and advanced knowledge of USFDA, ICH, EMA Guidelines, and USP General Chapters. Qualifications: - M. Pharm. - M. Sc. (Chemistry/Biochemistry) Amneal is an equal opportunity employer that values diversity and inclusion. The Human Resources team, with its various roles including Executive, Audit, Facilitator, Consultancy, and Service, partners with all aspects of the organization to drive success through effective people management.,