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: 1-5 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: 1-5 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: ₹15,000.00 - ₹60,000.00 per month
Benefits:
Work Location: In person
