Executive - QC Tech Writer

Amneal Pharmaceuticals

1 - 4 years

3 - 7 Lacs

Ahmedabad

Posted:2 days ago| Platform:

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Skills Required

QC Executive QOS Anda Packaging Instrumentation data integrity Material testing Product testing Analytical method validation Testing

Work Mode

Work from Office

Job Type

Full Time

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

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