Key Responsibilities

- Perform chemical and instrumental analysis of raw materials, in-process samples, finished products, packaging materials, and stability samples.

- Operate and maintain laboratory instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Dissolution Apparatus, Karl Fischer Titrator, TOC Analyzer, and pH Meter.

- Review analytical data, calculations, and laboratory records for accuracy and compliance.

- Ensure timely completion of sample analysis and release activities.

- Prepare, review, and maintain analytical reports, logbooks, SOPs, specifications, and test methods.

- Conduct laboratory investigations for Out of Specification (OOS), Out of Trend (OOT), deviations, and laboratory incidents.

- Participate in method validation, method verification, method transfer, and analytical troubleshooting.

- Monitor laboratory compliance with GMP, GLP, data integrity, and regulatory requirements.

- Coordinate calibration, qualification, and preventive maintenance of laboratory equipment.

- Support internal audits, customer audits, and regulatory inspections.

- Train and mentor junior QC analysts and technicians.

- Ensure proper inventory management of laboratory chemicals, reagents, reference standards, and consumables.

- Follow EHS (Setting, Health & Safety) guidelines and laboratory safety procedures.

- Drive continuous improvement initiatives within the QC laboratory.

Required Qualifications

- Bachelor's or Master's degree in Pharmacy, Chemistry, Pharmaceutical Chemistry, Analytical Chemistry, or a related life sciences discipline.

- 5–10 years of experience in Quality Control within a pharmaceutical manufacturing company.

- Strong knowledge of GMP, GLP, ICH guidelines, pharmacopeias (USP, BP, IP, EP),



and regulatory requirements.

- Hands-on experience with HPLC, GC, UV, FTIR, Dissolution, and other analytical instruments.

- Experience in OOS/OOT investigations, method validation, and stability testing.

- Familiarity with documentation practices and data integrity requirements (ALCOA+ principles).

Required Skills

- Strong analytical and problem-solving skills.

- Excellent documentation and report-writing abilities.

- Leadership and team management skills.

- Good communication and interpersonal skills.

- Ability to work under deadlines while maintaining high-quality standards.

- Proficiency in Microsoft Office and laboratory documentation systems.

Key Performance Indicators (KPIs)

- On-time sample testing and report issuance.

- Compliance with GMP, GLP, and SOP requirements.

- Laboratory investigation closure within defined timelines.

- Audit and inspection readiness.

- Reduction in analytical errors and repeat testing.

- Instrument uptime and calibration compliance.

- Training completion and competency development of team members.

Preferred Experience

- Experience in regulatory-approved manufacturing facilities (USFDA, MHRA, EMA, WHO-GMP, or similar).

- Experience with LIMS, Empower, Chromeleon, or other chromatography data systems.

- Knowledge of quality risk management and continuous improvement tools.

Working Conditions

- Laboratory-based role within a pharmaceutical manufacturing environment.

- May require shift work and support during audits, validations, and regulatory inspections.

- Experience
- 5-8 years

Pay: ₹30,000.00 - ₹35,000.00 per month

Benefits

- Cell phone reimbursement

- Paid sick time

- Paid time off

- Provident Fund

Work Location: In person

📌 Senior Analytical Chemist (Bhopal)
🏢 HIND PHARMA
📍 Bhopal