Formulation Analytical Research & Development (Hetero)
6/7/20261 min read
Roles and Responsibilities
Key Responsibilities
Analytical Activities
Perform analysis of raw materials, in-process samples, finished products, and stability samples.
Operate and maintain analytical instruments such as HPLC, UPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution Apparatus, and KF Titrator.
Support analytical method development and method validation activities.
Execute routine testing as per approved analytical procedures and specifications.
Assist in troubleshooting analytical issues during product development.
Documentation
Maintain laboratory notebooks, raw data, analytical worksheets, and instrument logbooks.
Prepare analytical reports and data summaries.
Ensure compliance with Good Documentation Practices (GDP).
Stability Studies
Analyze stability samples as per approved protocols.
Record and report analytical observations accurately.
Support shelf-life determination studies for pharmaceutical products.
Compliance & Quality
Follow cGMP, GLP, Data Integrity, and laboratory safety requirements.
Ensure proper handling and disposal of chemicals and laboratory waste.
Participate in laboratory audits and compliance activities.
Cross-Functional Coordination
Coordinate with Formulation Development, Quality Control, and Regulatory Affairs teams.
Support technology transfer and scale-up activities whenever required.
Required Skills
Basic knowledge of pharmaceutical analytical techniques.
Understanding of HPLC, UV, Dissolution, and chromatographic principles.
Knowledge of ICH guidelines and analytical method validation concepts.
Good laboratory practices and documentation skills.
Strong analytical and problem-solving abilities.
Effective communication and teamwork skills.
Preferred Competencies
Exposure to pharmaceutical laboratory equipment during academics or project work.
Knowledge of Microsoft Excel, Word, and PowerPoint.
Ability to learn and adapt in a fast-paced R&D environment.
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