Role & responsibilities

- Execute analytical method development, validation, verification, and method transfer activities under the guidance of senior team members.

- Perform analytical testing including assay, related substances, dissolution, content uniformity, residual solvents, and stability studies.

- Operate and maintain analytical instruments such as HPLC, UPLC, GC, UV-Visible Spectrophotometer, Dissolution Apparatus, and other laboratory equipment.

- Prepare and maintain laboratory notebooks, analytical data, protocols, reports, and technical documents as per GDP requirements.

- Conduct forced degradation studies and support development of stability-indicating analytical methods.

- Review analytical results, report deviations, and assist in OOS/OOT investigations and CAPA implementation.

- Support analytical activities for formulation development, exhibit batches, scale-up, technology transfer, and regulatory submissions.

- Coordinate with Formulation R&D;, QA, Production, and Regulatory Affairs teams for smooth project execution.

- Ensure adherence to cGMP, GLP, data integrity,



EHS guidelines, and oncology handling & safety procedures.

- Maintain laboratory housekeeping, equipment logbooks, and calibration/qualification records.

Educational Qualification

- M.Pharm (Pharmaceutical Analysis) or equivalent qualification from a recognized university.

Technical Competencies

- Hands-on experience in pharmaceutical analytical testing and method development support.

- Knowledge of HPLC, UPLC, GC, UV Spectrophotometer, Dissolution Apparatus, and related analytical instruments.

- Understanding of ICH guidelines, pharmacopoeial requirements (USP/EP/IP), cGMP, GLP, and data integrity practices.

- Knowledge of impurity analysis, stability studies, forced degradation, and analytical data interpretation.

- Familiarity with analytical documentation, method transfer, and regulatory requirements for generic products.

Interested candidates can apply or share their resume on [email protected]

📌 Executive - ARD Oncology (Navi Mumbai)
🏢 Umedica Labs
📍 Navi Mumbai