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 Valuable 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

📌 Urgent Opernings in Quality Control - IIEPL (Sathyavedu)
🏢 International Ingredients u0026 Excipients
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