Assistant Manager - QC Tech Writer

• Creation/Revision/ Review of Specifications and Methods for Site Transfers and ANDAs
•  Method Validation Protocol knowledge.
• Creation/Revision/ Review of Validation Repot for Drug substance, Excipients and Drug products.
• Initiate Change controls as necessary for:

            Method and specification revisions and stability Protocol 

• Modules preparation for Drug substance and Drug product. 
  • Batch Analysis – 32S/32P
  • Reference Standards – 32S/32P
  • Characterization of Impurities – 32S/32P
  • Justification of Specification – 32S/32P
  • Facility Templates
  • Stability Summary Reports for ACC, CRT & RT
  • 5313 Reports (Dissolution Comparative test)
  • QOS & Stability Overview - 32S/32P (If ANDA)
•  To prepare vendor qualification report based on the performance of material at test.
•  To prepare justification reports towards reduction of tests in Input material testing such as raw and packaging material; In-process testing; Finished product testing; Stability testing.
• Preparation/Review of SOPs 
• Preparation of cleaning validation method protocol and report

Required Skills 

• Data Integrity (ALCOA+ principles) | Advanced 
• Regulatory knowledge (USFDA, MHRA, ICH Q series) | Advanced 
• Method Validation Documentation | Advanced 
• Method Development Understanding | Advanced 
• CTD / eCTD Module Preparation (Primarily Module 3.2.S & 3.2.P) | Advanced 

M. Pharmacy / M. Sc

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.