04 Aug
|
Venus Remedies (VRL)
|
India
04 Aug
Venus Remedies (VRL)
India
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.
Valuable 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.
Positive 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 (India)
🏢 Venus Remedies (VRL)
📍 India