Jobs at Arni Medica - IVD Diagnostics

We are seeking a motivated and detail-oriented Junior QA Executive to join its Quality Assurance team. This entry-level role offers practical exposure to Quality Management Systems (QMS), quality documentation, manufacturing compliance, validation activities, and regulatory requirements within a medical device manufacturing environment. The selected candidate will support SOP preparation and document control, review Batch Manufacturing Records (BMR) and Device History Records (DHR), assist with in-process quality assurance and line clearance activities, and contribute to audits, deviations, Corrective and Preventive Actions (CAPA), and change control documentation. The ideal candidate will have a basic understanding of quality assurance principles, strong documentation skills, attention to detail, and a willingness to learn and work in a regulated manufacturing and cleanroom environment.

• 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.

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

Work experience:

• 0-1 years