Role & responsibilities

AR&D; Roles and Responsibilities
Develop analytical methods for APIs, intermediates, and raw materials.
Perform method validation according to ICH Q2(R2) guidelines.
Conduct method transfer to the Quality Control (QC) laboratory.
Perform method verification and method optimization when required.
Analyze samples using instruments such as:
HPLC
GC
UV-Visible Spectrophotometer
FTIR
Karl Fischer titrator
Dissolution apparatus (if applicable)
Perform forced degradation (stress studies) to establish stability-indicating methods.
Support stability studies by testing stability samples.
Investigate Out of Specification (OOS) and Out of Trend (OOT) results related to analytical methods.
Prepare and review analytical protocols, reports, and Standard Operating Procedures (SOPs).




Maintain accurate documentation following Positive Documentation Practices (GDP).
Ensure compliance with cGMP, GLP, and ICH guidelines.
Troubleshoot analytical instruments and coordinate with maintenance/calibration teams.
Support regulatory submissions by providing analytical data and documentation.
Participate in internal, customer, and regulatory audits.

Skills Required
Valuable knowledge of HPLC, GC, UV, FTIR, and KF.
Understanding of method development, method validation, and method transfer.
Knowledge of ICH, cGMP, GLP, GDP, and data integrity requirements.
Solid analytical, troubleshooting, and documentation skills.

Preferred candidate profile

📌 Analytical Research And Development Telangana (India)
🏢 The Pharma Patashala
📍 India