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 Good 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.
- Strong analytical, troubleshooting, and documentation skills.

Preferred candidate profile

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