CLAPS Industries Hiring QA Documentation Executive

CLAPS Industries Private Limited, we are dedicated to transforming healthcare through innovative pharmaceutical manufacturing. As a leading name in the industry, our commitment to quality, safety, and innovation drives everything we do.

Post : QA DOCUMENTATION EXECUTIVE (Interested in Regulatory Affairs)

JOB SUMMARY
We are looking for a QA Documentation professional with 2+ years of experience who is interested in building a career in Regulatory Affairs. The candidate should have strong knowledge of GMP documentation practices and a willingness to learn and handle regulatory activities for ROW markets.

KEY RESPONSIBILITIES
• Preparation and control of SOPs, STPs, specifications, formats, and master documents.
• Review of BMR, BPR, deviations, change controls, and CAPA records.
• Maintenance of document management systems and archival records.
• Preparation and compilation of CTD/ACTD dossiers.
• Handling product registrations, renewals, and variations for ROW markets.
• Coordination with QA, QC, Production, Purchase, and Regulatory teams.
• Ensuring compliance with GMP, GDP, and ICH guidelines.
• Responding to regulatory queries and maintaining submission trackers.

Candidate Profile
• B.Pharm / M.Pharm or relevant qualification
• Minimum 2 years of experience in QA Documentation.
• Knowledge of GMP, GDP, Documentation Control, Deviations, CAPA, and Change Control.
• Interest in transitioning to or growing within Regulatory Affairs.
• Good communication and documentation skills.
• Proficiency in MS Office.
• Basic knowledge of CTD/ACTD dossier preparation. Understanding of ICH guidelines and ROW market registrations.
Strong attention to detail and compliance-oriented mindset.

LOCATION : B-1202, Infinity Tower, Beside Hotel Ramada, 60 Feet Road, Prahladnagar, Ahmedabad - 380015, Gujarat, India
DEPARTMENT : Quality Assurance / Regulatory Affairs
EXPERIENCE : 2+ Years