Job Description

Job Title: Junior/Mid-Level Analyst - HPLC, UV, Dissolution, Assay, RS, and Method Validation

Company: KMS Healthcare Pvt. Ltd.

Department: Quality Control / Analytical R&D

Experience: 2-10 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:

2-10 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 600059

Note:

Experience in the relevant/same field.

Please Share resume Mobile # +91 9500112999 (WhatsApp)

Job Types: Full-time, Permanent

Pay: ₹35,000.00 - ₹70,000.00 per month

Benefits:

Provident Fund
Work Location: In person