Senior Production Associate

Job Summary:

The Senior Production Associate is responsible for overseeing the preparation, dispensing, and quality compliance of buffers and reagents for nucleic acid extraction kits. The role involves hands-on manufacturing, chemical handling, process documentation in SAP, and supporting process validation activities for new product development.

Key Responsibilities:

1. Buffer & Reagent Preparation

• Independently prepare buffers and reagents for DNA/RNA extraction kits as per batch manufacturing records (BMR).
• Ensure pH, conductivity, and other specifications are met during preparation.

2. Chemical & Reagent Management

• Manage inventory and safe handling of laboratory chemicals and raw materials.
• Ensure proper labeling, MSDS availability, and storage in compliance with HSE guidelines.

3. Buffer Dispensing Operations

• Dispense prepared buffers and reagents into suitable primary containers under controlled conditions.
• Ensure accuracy, hygiene, and aseptic techniques are maintained during the process.

4. SAP Documentation Work Orders

• Execute and close production-related work orders in SAP.
• Record real-time data for raw material consumption, batch output, and process deviations.

5. In-Process QC of Buffers & Reagents

• Perform in-process checks and basic QC validation (pH, color, clarity, etc.) before release.
• Coordinate with the QC team for sampling and release.

6. Support for New Product Validation (D&D)

• Accompany the Assistant Manager in Design & Development (D&D) activities.
• Support process validation (IQ, OQ, PQ) and scale-up for new product lines.

7. Manufacturing Line Ownership

• Take end-to-end responsibility for the extraction kit manufacturing line.
• Ensure timely completion of assigned batches and report any delays or issues.

8. Equipment Handling & Validation

• Operate and maintain production equipment (magnetic racks, filling lines, mixers, etc.).
• Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of new and existing equipment.

Key Requirements:

• Education: B.Sc. / M.Sc./ B.Tech/ M.Tech in Biotechnology, Biochemistry, Life Sciences, or related disciplines
• Experience: 03 years in IVD, Biotech, or Molecular Diagnostic Kit production

Skills Required:

• Strong knowledge of buffer chemistry, sterile techniques, and reagent formulation
• Hands-on experience with SAP production modules
• Familiarity with ISO 13485, GMP, and QMS documentation
• Understanding of equipment validation (IQ/OQ/PQ)