Senior Analytical Chemist

Job Title: Middle-Level Analyst – HPLC, UV, Dissolution, Assay, RS, and Method Validation
Company: KMS Healthcare Pvt. Ltd.
Department: Quality Control / Analytical R&D
Experience: 3-7 years in pharmaceutical analysis

Job Summary:

We are seeking an experienced Analyst with expertise in HPLC, UV-Vis spectroscopy, dissolution testing, assay, related substances (RS), and method validation as per ICH guidelines. The candidate will be responsible for conducting analytical testing, preparing protocols/reports, and ensuring compliance with regulatory standards.

Key Responsibilities:1. Analytical Testing & Instrumentation:

• Perform routine and non-routine analysis using HPLC, UV-Vis, dissolution apparatus, and other lab instruments.
• Conduct assay, related substances (RS), dissolution, and stability testing as per pharmacopeial methods (USP/EP/BP/IP).
• Troubleshoot and maintain analytical instruments (HPLC, UV spectrophotometer, dissolution apparatus).

2. Method Validation & Transfer:

• Prepare and execute method validation/verification protocols (Accuracy, Precision, Linearity, Specificity, LOD/LOQ, Robustness) as per ICH Q2(R1).
• Support method transfer activities between labs or sites.

3. Documentation & Compliance:

• Prepare analytical reports, validation protocols, and reports in compliance with GMP/GLP.
• Review and ensure data integrity (ALCOA+ principles).
• Follow SOPs, pharmacopeial guidelines (USP/EP), and ICH requirements.

4. Regulatory & Audits:

• Support regulatory submissions (ANDAs, DMFs) with analytical data.
• Participate in internal/external audits (FDA, WHO, MHRA).

5. Cross-Functional Collaboration:

• Work with QA, R&D, and production teams for investigations (OOS/OOT, deviations).
• Train junior analysts on analytical techniques and compliance.

Qualifications & Skills:

• Education: Bio Technology/ M.Sc./B.Pharm/M.Pharm in Chemistry/Pharmaceutical Sciences.
• Experience: 3-7 years in pharmaceutical QC/ADL labs, with hands-on experience in:
• HPLC/UPLC (Method development/validation preferred).
• UV-Vis spectroscopy, dissolution testing (Apparatus I/II).
• Assay, RS, forced degradation studies.
• Regulatory Knowledge: ICH, USFDA, GMP, GLP.
• Software: Empower, LabSolutions, Dissolution software.
• Soft Skills: Detail-oriented, problem-solving, teamwork.

Preferred:

• Experience in oral solid dosages (tablets/capsules).
• Knowledge of impurity profiling, stability studies (ICH Q1A).

Why Join Us?

• Opportunity to work in a GMP-compliant lab with advanced instrumentation.
• Career growth in analytical development/validation.
• Exposure to global regulatory standards.

Job Type: Full-time

Location:

Door No.6, Kamarajar St, East Tambaram, Selaiyur, Chennai, Tamil Nadu 600059Job .

Job Type: Full-time

Pay: ₹30,000.00 - ₹60,000.00 per month

Schedule:

• Day shift
• Morning shift

Work Location: In person

Expected Start Date: 25/07/2025