Senior Executive Quality Control - USFDA

Job Description

We are hiring a Senior Executive – Quality Control for an API pharmaceutical company located in Vapi.

The candidate will be responsible for handling QC operations with strong focus on USFDA compliance and regulatory standards.

Only candidates with USFDA experience and API Pharma background will be considered.

Key Responsibilities

• Perform analysis of raw materials, intermediates, and finished API products.
• Operate and maintain instruments such as HPLC, GC, UV, and other analytical equipment.
• Ensure compliance with USFDA, GMP, and GLP guidelines.
• Handle documentation, SOPs, and regulatory requirements.
• Conduct OOS, OOT, and deviation investigations.
• Participate in USFDA audits and regulatory inspections.
• Maintain laboratory records and ensure data integrity.
• Coordinate with QA and production teams for quality assurance.

Required Skills

• Strong experience in API Pharma Quality Control.
• Hands-on experience with USFDA audits and compliance.
• Knowledge of analytical instruments (HPLC, GC, UV).
• Understanding of GMP/GLP and regulatory documentation.
• Ability to handle quality investigations and audits.
• Strong analytical and problem-solving skills.
• Attention to detail and data accuracy.