Production Executive

Department: Production

Industry: IVD – Rapid Test Kits & ELISA

Qualification: B.Sc. / M.Sc. (Life Sciences, Biotechnology, Microbiology, Biochemistry) or B.Pharm / M.Pharm or a related discipline.

Experience: 3–5 Years (Experience in IVD, Medical Devices, Diagnostics, or Pharmaceutical Manufacturing preferred)

Location: Netaji Subhash Place, New Delhi

Job Profile:

Astam Diagnostics Pvt. Ltd. is looking for a dedicated and detail-oriented Production Executive to support the manufacturing of Rapid Test Kits and ELISA Products. The ideal candidate should have hands-on experience in production operations, process control, documentation, and compliance with quality standards in an IVD, Medical Device, Diagnostics, or Pharmaceutical manufacturing environment. The candidate will work closely with the Production, Quality Assurance, Quality Control, and Supply Chain teams to ensure smooth production and timely delivery of high-quality products.

Key Responsibilities:

• Execute daily production activities as per the approved production plan.
• Manufacture Rapid Test Kits and ELISA products in accordance with approved SOPs and Batch Manufacturing Records (BMR).
• Ensure production targets are achieved while maintaining product quality and efficiency.
• Monitor production processes and identify opportunities for continuous improvement.
• Coordinate with Quality Assurance (QA) and Quality Control (QC) teams to ensure compliance with quality standards.
• Maintain accurate production records, batch documentation, logbooks, and production reports.
• Ensure compliance with GMP, ISO 13485, and other applicable regulatory requirements.
• Monitor equipment performance and coordinate preventive maintenance activities.
• Ensure proper utilization of raw materials and minimize production wastage.
• Maintain cleanliness, safety, and discipline within the production area.
• Coordinate with Procurement and Stores to ensure timely availability of production materials.
• Support process validation, technology transfer, and new product development activities whenever required.

Required Skills & Qualifications:

• B.Sc. / M.Sc. (Life Sciences, Biotechnology, Microbiology, Biochemistry), B.Pharm / M.Pharm, or equivalent qualification.
• 3–5 years of production experience in IVD, Diagnostics, Medical Devices, or Pharmaceutical Manufacturing.
• Good understanding of Rapid Diagnostic Kits, ELISA products, or related manufacturing processes.
• Knowledge of GMP, ISO 13485, documentation practices, and quality systems.
• Ability to prepare and maintain Batch Manufacturing Records (BMR) and production documentation.
• Strong problem-solving, analytical, and organizational skills.
• Good communication and teamwork abilities.
• Basic knowledge of MS Office applications.
• Ability to work efficiently in a fast-paced manufacturing environment.

Preferred Candidate Profile:

• Experience in manufacturing Rapid Test Kits, Lateral Flow Assays, ELISA Kits, or other IVD products.
• Knowledge of cleanroom practices and controlled manufacturing environments.
• Exposure to ISO 13485, WHO-GMP, and Medical Device Quality Management Systems.
• Self-motivated, detail-oriented, and committed to delivering high-quality production output.