Posted:3 weeks ago|
Platform:
Work from Office
Full Time
Role & responsibilities Development and validation of analytical methods for drug substances and drug products. Preparation of method development reports (MDR), method validation protocols (MVP), and method validation reports (MVR). Handling and operation of analytical instruments like HPLC, GC, UV-Vis, dissolution apparatus, etc. Routine analysis of development, stability, and exhibit batches with complete documentation. Evaluation and interpretation of analytical data to support formulation and stability studies. Conducting forced degradation and compatibility studies. Preparation of analytical specifications and standard test procedures (STPs) for raw materials and finished products. Literature review and evaluation of pharmacopeial and non-pharmacopeial methods. Reference product (RLD) characterization including comparative dissolution and impurity profiling. Calibration, qualification, and maintenance of analytical instruments as per SOP. Coordination with formulation, QA, QC, and regulatory teams for analytical support. Ensuring compliance with GLP, data integrity, and good documentation practices. Archival and retrieval of analytical data and reports. Training and mentoring of junior team members in analytical techniques and practices. Any other responsibilities assigned by Analytical or R&D Head.
Allrite Pharmaceuticals
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