Urgent Opernings in Quality Control - IIEPL (Sathyavedu)

International Ingredients & Excipients; Amaravati; On-site; INR 450,000 - 700,000; Full time

Job summary

International Ingredients & Excipients is seeking a skilled Analytical Chemist to perform testing of raw materials, in-process samples, and finished products in a GMP/GDP environment.

The role involves instrument operation (HPLC, GC, UV-Vis), method validation support, documentation, and compliance with regulatory standards. Candidates should have strong analytical problem-solving skills and effective teamwork in a lab setting.

Qualifications

• Experience in GMP/GLP documentation and data integrity practices.
• Familiarity with pharmacopoeias and approved test methods.

Responsibilities

• Perform analysis of raw materials, in-process samples, finished products, and stability samples.
• Conduct chemical, physical, and instrumental analyses as per specifications.
• Test purified water, potable water, and environmental monitoring samples.
• Prepare and standardize reagents and reference standards.
• Operate and maintain analytical instruments and ensure calibration/maintenance.

Skills

GMP/GLP knowledge

Pharmacopoeias (IP, USP, BP, EP)

Analytical problem-solving

HPLC operation

GC operation

Documentation skills

OOS/OOT investigations

MS Office proficiency

Teamwork & communication

Time management

Tools

HPLC

GC

UV-Vis Spectrophotometer

FTIR

Dissolution Apparatus

pH Meter

Karl Fischer Titrator

TOC Analyzer

Job description

Role & responsibilities

Key Roles & Responsibilities

Sample Testing & Analysis

• Perform analysis of raw materials, packaging materials, in-process samples, finished products, and stability samples.
• Conduct chemical, physical, and instrumental analysis as per approved specifications and test methods.
• Test purified water, potable water, and environmental monitoring samples where applicable.
• Prepare and standardize reagents, volumetric solutions, and reference standards.

Instrument Operation

• Operate and maintain analytical instruments such as:
  • HPLC
  • GC
  • UV-Visible Spectrophotometer
  • FTIR
  • Dissolution Apparatus
  • pH Meter
  • Karl Fischer Titrator
  • TOC Analyzer (where applicable)
• Ensure calibration and preventive maintenance of laboratory equipment.

Documentation & Compliance

• Record analytical data accurately in laboratory notebooks and approved formats.
• Prepare Certificates of Analysis (COA).
• Review analytical results against specifications.
• Follow Good Documentation Practices (GDP).
• Maintain compliance with GMP, GLP, data integrity (ALCOA+), and regulatory requirements.

Laboratory Activities

• Maintain laboratory cleanliness and safety.
• Ensure availability of chemicals, reagents, glassware, and consumables.
• Manage reference standards and working standards.
• Support laboratory investigations and out-of-specification (OOS) activities.

Quality & Regulatory Compliance

• Follow SOPs, specifications, and standard test procedures.
• Participate in internal audits and regulatory inspections.
• Assist in investigations related to OOT (Out of Trend), deviations, CAPA, and change control.
• Support method validation, method verification, and analytical method transfer.

Stability Program

• Perform stability sample testing according to approved stability protocols.
• Maintain stability chambers and documentation.
• Report stability trends to management.

Safety

• Follow laboratory safety procedures.
• Handle hazardous chemicals safely.
• Ensure proper disposal of laboratory waste.

Preferred candidate profile

Required Skills

• Knowledge of GMP, GLP, GDP, and Data Integrity
• Knowledge of pharmacopoeias (IP, USP, BP, EP)
• Analytical and problem-solving skills
• HPLC and GC operation
• Documentation skills
• Investigation handling (OOS/OOT)
• MS Office proficiency
• Teamwork and communication skills
• Time management