Team Member - Quality Control

A Quality Control Analyst is responsible for performing analytical testing of raw materials, in-process samples, finished products, and stability samples in compliance with GMP, regulatory guidelines, and company SOPs. The role ensures accurate, reliable, and timely reporting of results to support product quality and batch release.

Key Responsibilities:

1. Analytical Testing

• Perform analysis of RM, PM, in-process, finished products, and stability samples.
• Operate analytical instruments such as:
  • HPLC, GC, UV, IR, KF, Dissolution Apparatus
• Ensure proper documentation of analytical data.

2. Data Handling & Documentation

• Record results in LIMS / worksheets / logbooks as per GDP practices.
• Review data for accuracy and completeness before submission.
• Maintain raw data traceability and integrity.

3. Instrument Handling

• Perform routine calibration and system suitability checks.
• Ensure proper maintenance and cleaning of instruments.
• Report any instrument malfunction to the supervisor.

4. Compliance & GMP

• Follow cGMP, GLP, and data integrity requirements (ALCOA principles).
• Adhere to SOPs, STPs, and safety guidelines.
• Participate in audits and provide required data/documents.

B.Sc / M.Sc (Chemistry / Analytical Chemistry) or B.Pharm

Required Skills:

• Knowledge of analytical techniques and instrumentation
• Understanding of GMP, GLP, and regulatory requirements
• Familiarity with Empower / LIMS systems
• Good documentation and data integrity practices
• Attention to detail and accuracy
• Basic investigation and problem-solving skills

Key Competencies:

• Strong analytical mindset
• Accountability and ownership
• Time management (meeting batch timelines)
• Team coordination
• Compliance-focused approach