Jr QA Executive

Job highlights

• We are seeking enthusiastic and detail-oriented fresh graduates to join our Quality Assurance (QA) team
• Review Batch Manufacturing Records (BMR) and Device History Records (DHR)
• Skills Required
• Ensure Good Documentation Practices (GDP) across departments

Job Summary

Arni Medica is a leading medical device manufacturer specializing in contract manufacturing, new product development, and high-quality production of nephrology and healthcare products. We are seeking enthusiastic and detail-oriented fresh graduates to join our Quality Assurance (QA) team. This role provides exposure to quality systems, documentation, and regulatory compliance in a medical device manufacturing environment.

Key Responsibilities

• Assist in implementation and maintenance of Quality Management System (QMS).
• Support preparation, review, and control of SOPs, formats, and QA documents.
• Ensure Good Documentation Practices (GDP) across departments.
• Review Batch Manufacturing Records (BMR) and Device History Records (DHR).
• Assist in in-process quality assurance activities and line clearances.
• Support validation activities (IQ/OQ/PQ) and equipment qualification documentation.
• Participate in internal audits and assist during external audits (ISO 13485, GMP).
• Help in handling deviations, CAPA, and change control documentation.
• Ensure compliance with ISO 13485, GMP, and regulatory requirements.
• Maintain training records and assist in QA-related training programs.

Qualifications & Skills

Education:

• B.Pharm / M.Pharm, or B.Sc / M.Sc in Life Sciences, Biotechnology, Microbiology, Chemistry or B.Tech / Diploma in Biomedical Engineering

Skills Required

• Basic knowledge of QA concepts and documentation practices
• Understanding of ISO 13485, GMP (basic level) is an advantage
• Strong attention to detail and willingness to learn
• Good documentation, analytical, and communication skills
• Ability to work in a regulated cleanroom and manufacturing environment