Assistant Manager - QC Tech Writer

You will be responsible for creating, revising, and reviewing specifications and methods for site transfers and ANDAs. You should have knowledge of method validation protocols and be able to create, revise, and review validation reports for drug substance, excipients, and drug products. It will be your duty to initiate change controls as necessary for various aspects including method and specification revisions, stability protocols, batch analysis, reference standards, characterization of impurities, justification of specifications, facility templates, stability summary reports, 5313 reports, QOS, and stability overview. You will also prepare vendor qualification reports based on the performance of materials during testing and justification reports for reducing tests in input material testing, in-process testing, finished product testing, and stability testing. Additionally, you will be involved in the preparation and review of SOPs and cleaning validation method protocols and reports. As for the required skills, you should have advanced knowledge in data integrity (ALCOA+ principles), regulatory requirements (USFDA, MHRA, ICH Q series), method validation documentation, method development understanding, and CTD/eCTD module preparation primarily in Module 3.2.S & 3.2.P. Qualifications required for this role include an M. Pharmacy or M. Sc degree. Amneal is an equal opportunity employer that values diversity and inclusion. The Human Resources team at Amneal plays a crucial role in partnering with all aspects of the organization to drive success through effective people management. The team performs key roles such as specialists in people management, ensuring compliance with legal requirements and best practices, facilitating support and advice for various aspects of the organization, providing expert consultancy on workforce management and employee relations, and ensuring the organization is equipped to deal with developments impacting employment matters.,