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

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