Job description :

The R&D; & Production Sr. Executive is responsible for planning, executing, and coordinating Research & Development (R&D;) activities together with production operations for In Vitro Diagnostic (IVD) product. The role ensures successful product development, process optimization, scale-up, technology transfer, and commercial manufacturing while maintaining compliance with ISO 13485, GMP, applicable regulatory requirements, and the company's Quality Management System (QMS). The position supports the complete product lifecycle from concept development to commercial production by collaborating with Quality Assurance, Quality Control, and other cross-functional teams to deliver safe, reliable, and high-quality IVD products.

2.0 KEY RESPONSIBILITIES AND DESCRIPTION:

2.1 R&D; & PRODUCTION SR. EXECUTIVE:

- 2.1.1 Plan, organize, and Execute research and development projects.
- 2.1.2 Develop new products and improve existing formulations/processes.
- 2.1.3 Handle product transfer from R&D; to production scale-up.
- 2.1.4 Evaluate new raw materials and alternate components for product enhancement and cost optimization.
- 2.1.5 Commercial batch manufacturing.
- 2.1.6 Ensure compliance with regulatory, safety, and quality requirements.
- 2.1.8 Prepare, review, and maintain SOPs, Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), Specifications, Validation Protocols, Technical Files, and Development Reports.
- 2.1.9 Filling Batch Manufacturing Records (BMR), Batch Packaging Records (BPR)



and other documents of Production department.
- 2.1.10 Maintain complete and accurate records following Good Documentation Practices (GDP)
- 2.1.11 Work closely with QA and QC to ensure product quality throughout the manufacturing process.
- 2.1.12 Manage laboratory activities, trials, and validation studies.
- 2.1.13 Monitor project timelines, budgets, and resource allocation.
- 2.1.14 Train production personnel on manufacturing procedures, GMP, SOPs, safety practices, and documentation requirements.
- 2.1.15 Support internal audits, external audits, customer audits, and regulatory inspections.
- Ensure proper utilization of manpower, equipment, materials, and production resources.

3.0 AUTHORITIES OF R&D; & PRODUCTION SR. EXECUTIVE

- 3.1 Plan and execute approved R&D; projects and production activities.
- 3.2 Prepare technical documents before submission for managerial approval.
- 3.3 Recommend revision of SOPs, specifications, manufacturing records, and technical documents whenever required.
- 3.4 Recommend approval or rejection of development raw materials based on technical evaluation.
- 3.5 Coordinate technology transfer and validation activities.

Pay: ₹25,000.00 - ₹50,000.00 per month

Advantages:

- Paid time off
- Provident Fund

Ability to commute/relocate:

- Chhatral, Vadodara, Gujarat: Reliably commute or planning to relocate before starting work (Preferred)

Education:

- Master's (Preferred)

Experience:

- ISO 13485: 2 years (Required)

Work Location: In person

📌 Research and Development Executive (Chhatral)
🏢 Labgene Biotech
📍 Chhatral