Analytical Specialist

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.