Senior Officer QA

Meril GmbH; India; In loco; INR 180.000 - 300.000; Tempo pieno

Descrizione del lavoro

Meril GmbH is seeking a candidate with 0–2 years of experience in the Medical Device/Pharma industry to join the qualification and validation team. The role involves monitoring validation activities, preparing technical files, and reviewing data across multiple manufacturing segments.

The successful candidate will support protocol creation and the review of BMRs, analytical reports and related documentation, ensuring GMP compliance and regulatory alignment.

Competenze

• 0–2 years of experience in Medical Device/Pharma industry.
• Experience with IQ/OQ/PQ qualifications.
• GMP compliance & regulatory documentation experience.
• Preparation and review of technical files.
• Review of raw data and analytical reports.

Mansioni

• Monitor qualification and validation activities.
• Prepare technical files and related documentation.
• Prepare and review qualification & validation protocols and reports.
• Review raw data including analytical reports, BMRs, batch release certificates, data mapping reports, etc.
• Support validation activities across multiple manufacturing segments.

Conoscenze

Qualification monitoring

Validation activities

Technical documentation

Data review

Descrizione del lavoro

DELIVERINGWORLD-CLASS HEALTHCARE SOLUTIONS

Founded in 2006, Meril is an India-based, global medical devicecompany that is dedicated to the innovation, design and developmentof novel, clinically relevant and state-of-the-art devices. Ourfundamental aim is to champion the alleviation of human sufferingand improve quality of life. To enable this, we are committed toR&D, innovation in manufacturing medical technology, scientificcommunication, and contemporary distribution avenues.

Meril was born with the aim of improving the quality of humanlife through innovative and advanced healthcare solutions. As amedical device manufacturer, we exist to improve the inventivenessin healthcare so that people’s lives are enriched. We continuallyseek excellence in providing answers to some of medicine’s toughest questions.

Meril manufactures medical solutions in the form of vascularintervention devices, orthopaedic supplements, in-vitro diagnostics,endo-surgery and ENT products. It is our core commitment to ensurethe delivery of advance healthcare solutions. Our inclinationtowards research and development is reflected in our diverseofferings. We ensure that we adhere to the best quality of standardsin manufacturing, scientific communication and distribution todeliver path-breaking healthcare products to the world.

We collaborate with physicians and global innovators to identifyunmet clinical needs and develop revolutionary therapies. Weencourage research and academic collaborations and remain availableto interact on exciting opportunities.

Headquartered in India with a manpower of more than 4000, Merilcurrently conducts business in more than 100 countries. We have 100%subsidiaries in India, USA, Germany, Brazil, Russia, South Africa,Bangladesh and Turkey. We have set up operations in China and Japan too.

Job Description

0-2year experience in Medical Device/Pharma industry.

• Monitoringof qualification and validation activities.
• Preparationof technical files and related documentation.
• Preparationand review of qualification & validation protocols and reports.
• Reviewof raw data, including analytical reports, BMRs, job cards, batch releasecertificates, data mapping reports, etc.
• Support validationactivities across multiple manufacturing segments

Requirements

Qualification & Validation (IQ/OQ/PQ)

Technical Documentation & Technical File Preparation

Protocol and Report Preparation & Review

GMP Compliance & Regulatory Documentation

Batch Manufacturing Records (BMR) & Analytical Report Review

Cross-functional Coordination & Validation Support