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.
- 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:
· Fresher or Experience in the relevant/same field.
Please share your resume and mobile number +91-9500112999 (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
