Executive - QC Tech Writer

Job Description: 

• 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 

Required Skills:

• Analytical method Validation documentation : Advanced
• Laboratory Instrumentation Knowledge : Intermediate
• Data Integrity (ALCOA+ principles) : Advanced
• CTD / eCTD Module Preparation (Primarily Module 3.2.S & 3.2.P) : Advanced
• Impurity Profiling & Justification : Intermediate
• Stability Profiling Knowledge : 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.