Analytical Specialist

ConfidentialHyderabad / Secunderabad, Telangana

30+ days ago

Job description

Analytical Method Development & Validation :

Develop and validate analytical methods for assay, dissolution, related substances, and content uniformity as per ICH guidelines.
Troubleshoot and optimize analytical methods for new and existing OSD products (tablets, capsules, etc.).

Routine Analysis & Documentation :

Conduct analysis of raw materials, in-process samples, and finished products.

Prepare and review protocols, reports, method validation documents, and specifications.

Stability Studies :

Execute and monitor stability studies as per ICH guidelines.

Generate stability data and interpret results to support product registration.

Instrumentation Handling :

Operate and maintain sophisticated analytical instruments like HPLC, UV, FTIR, Dissolution Apparatus, GC, etc.

Ensure proper calibration and upkeep of instruments.

Regulatory Compliance :

Ensure all analytical activities comply with GLP / GMP and regulatory requirements.

Support regulatory submissions (ANDA, CTD, eCTD) with analytical documentation.

Cross-functional Support :

Collaborate with formulation, regulatory, QA, and production teams to support product development lifecycle.

Participate in technology transfer and scale-up activities.

Key Skills :

Sound knowledge of analytical chemistry and pharmaceutical analysis.

Hands-on experience with HPLC / GC / UV and dissolution testing.

Familiarity with ICH guidelines and regulatory requirements for US / EU / ROW markets.

Good documentation practices and data integrity awareness.

Ability to work in a fast-paced, cross-functional environment.

Skills Required

Data Analysis, Sql, Python, Statistical Modeling, Machine Learning, Data Visualization

Specialist • Hyderabad / Secunderabad, Telangana