Quality Control Manager – USFDA

Job Description

We are hiring a Quality Control Manager – USFDA for a capsule formulation company located in Daman.

The candidate will be responsible for managing QC operations with strong focus on USFDA compliance and capsule formulation standards.

Only candidates with USFDA experience and capsule (empty gelatin) formulation background will be considered.

Key Responsibilities

• Lead and manage Quality Control operations for capsule formulation products.
• Ensure compliance with USFDA, GMP, and GLP guidelines.
• Oversee analysis of raw materials, in-process, and finished products.
• Operate and monitor analytical instruments such as HPLC, GC, and UV.
• Review and approve laboratory documentation, reports, and SOPs.
• Handle OOS, OOT, and deviation investigations.
• Prepare and manage documentation for USFDA audits and inspections.
• Ensure data integrity and regulatory compliance.
• Train and manage QC team members.
• Coordinate with QA and production departments.

Required Skills

• Strong experience in capsule (empty gelatin) formulation QC.
• Hands-on experience with USFDA audits and regulatory requirements.
• Expertise in analytical instruments (HPLC, GC, UV).
• Knowledge of GMP/GLP and pharmaceutical documentation.
• Strong leadership and team management skills.
• Excellent analytical and problem-solving ability.
• High attention to detail and compliance standards.