Jr QA Executive
Posted Updated
Summary
Entry-level Quality Assurance role at Arni Medica, a medical device manufacturer in Patancheru, India, for fresh graduates. Day to day: maintaining the QMS and SOP documentation, reviewing batch/device history records, supporting validation (IQ/OQ/PQ), deviations/CAPA, and internal and external audits (ISO 13485, GMP).
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.
Requirements
- 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 Requried:
- 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