Job description:

Job Title: Analytical Chemist – HPLC, UV, Dissolution, Assay, RS, and Method Validation
Company: KMS Healthcare Pvt. Ltd.
Department: Analytical R&D; / Quality Control
Experience: 0-3 years in pharmaceutical analysis

Job Summary:

We are seeking an experienced Analytical Chemist 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: B.Sc/M.Sc in Chemistry and B.Pharm./M.Pharm./B.Tech-Biotechnology in Pharmaceutical Sciences or Life Science.
- Experience: 0-3 years in pharmaceutical ADL/QC labs,

with hands-on experience in:

- HPLC/UPLC (method development/validation preferred).
- UV-Vis spectroscopy and dissolution testing (Apparatus I/II).
- Assay, RS, forced degradation studies.
- Regulatory Knowledge: ICH, USFDA, GMP, GLP.
- Soft Skills: Detail-orientated, problem-solving, and 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.
- Growth opportunities 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 600059

Note:

· Fresher or Experience in the relevant/same field.

Please share your resume and mobile number +91-(phone hidden) (WhatsApp)

Benefits:

- Flexible schedule
- Provident Fund

Work Location: In person

Pay: ₹15,000.00 - ₹25,000.00 per month

Benefits:

- Flexible schedule
- Provident Fund

Work Location: In person

📌 Analytical Chemist (Selaiyur)
🏢 KMS Health Center
📍 Selaiyur