Job Responsibilities:

- Hands-on experience in analytical method development and validation.
- Practical knowledge of HPLC, GC, UV-Visible Spectrophotometer, and FTIR.
- Experience in analytical testing of drug substances (API) and drug products.
- Knowledge of analytical method transfer and troubleshooting.
- Understanding of ICH, USP, IP, BP, EP, and current regulatory guidelines.
- Good documentation practices (GDP) and data integrity (ALCOA+) awareness.
- Strong analytical, problem-solving, and communication skills.
- Ability to work effectively in a team-oriented environment.

Key Responsibilities

- Perform analytical method development, optimization, verification, and validation for APIs and pharmaceutical formulations.
- Conduct routine and non-routine analysis of raw materials, in-process samples, finished products, stability samples, and validation batches.
- Operate, calibrate, and maintain analytical instruments including HPLC, GC, UV-Visible Spectrophotometer, and FTIR.
- Prepare analytical protocols, standard operating procedures (SOPs), test methods, and analytical reports.




- Execute method validation and method transfer activities in accordance with ICH and regulatory guidelines.
- Investigate out-of-specification (OOS), out-of-trend (OOT), and analytical deviations, and assist in root cause analysis.
- Ensure accurate documentation in compliance with Good Documentation Practices (GDP) and Data Integrity requirements.
- Support stability studies, product development, technology transfer, and regulatory submission activities.
- Maintain laboratory safety, housekeeping, calibration records, and compliance with GMP and GLP requirements.
- Coordinate with Formulation R&D;, Quality Assurance, Regulatory Affairs, and Production teams to support development projects.

Preferred Competencies

- Knowledge of pharmaceutical analytical techniques and laboratory practices.
- Understanding of regulatory expectations for analytical development.
- Ability to interpret chromatographic and spectroscopic data.
- Good report writing and documentation skills.
- Self-motivated, detail-oriented, and eager to learn recent analytical techniques.

Preferred Industry

- Pharmaceutical Injectables
- Sterile Formulations

📌 Research Associate-ARD (Himachal Pradesh)
🏢 Venus Remedies (VRL)
📍 Himachal Pradesh