Engineer Trainee - Quality Assurance (QA)

Zeta Biosystem; Bengaluru; On-site; INR 250,000 - 450,000; Full time

Job summary

Zeta Biosystem in Bengaluru (Nelamangala) seeks an Engineer Trainee - Quality Assurance with 0-2 years of experience to support QA processes, prepare validation documents, and help ensure compliance across project lifecycles.

You will work with cross‑functional teams on DQ/IQ/OQ, FAT/SAT, PQP/QAP and review URS‑aligned documents such as P&ID, BOM, FDS and GA drawings, ensuring traceability and audit readiness.

Qualifications

• Solid understanding of QA and validation processes.
• Experience with qualification protocols (DQ/IQ/OQ).
• Familiarity with regulatory guidelines and documentation.
• Good coordination and communication skills.

Responsibilities

• Prepare and review qualification and validation documents, including DQ, IQ, OQ, FAT, SAT.
• Coordinate project activities with cross-functional teams.
• Review P&ID, BOM, FDS, GA drawings and manufacturing documents for URS alignment.
• Ensure audit trails compliance per 21 CFR Part 11.

Skills

Quality Assurance

Validation

Documentation

Coordination

Attention to detail

Tools

SCADA/HMI

Job description

Job Summary
We are looking for a detail-oriented and proactive Engineer Trainee - Quality Assurance with 0-2 years of experience to join our engineering team in Nelamangala, Bangalore. The candidate will be responsible for supporting quality assurance processes, preparing validation documentation, and ensuring compliance across project lifecycles.

Key Responsibilities

1. Quality Assurance & Documentation

• Responsible for Quality Assurance processes for DBS Engineering activities.
• Prepare qualification and validation documents, including:
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Pre-FAT, FAT, and SAT protocols
• Prepare Project Quality Plan (PQP) and Quality Assurance Plan (QAP).
• Develop and document Risk Assessments.

2. Project Coordination

• Coordinate projects in line with approved project plans.
• Work closely with cross-functional teams to ensure smooth execution during all project phases.

3. Document Review & Compliance

• Collect, review, and verify documents from various departments, including:
  • P&ID
  • BOM
  • FDS
  • GA drawings
  • Manufacturing documents
  • Component certificates
• Ensure all documentation aligns with User Requirement Specifications (URS).

4. Qualification & Validation Activities

• Prepare and review DQ documents against URS requirements.
• Execute qualification activities such as:
  • Pre-FAT (Pre-Factory Acceptance Test)
  • FAT (Factory Acceptance Test)
  • SAT (Site Acceptance Test)
• Actively participate in project execution stages and validation processes.

5. Systems Testing & Compliance

• Perform testing and operation of SCADA/HMI systems.
• Ensure compliance with audit trail requirements as per 21 CFR Part 11.

Required Skills & Competencies

• Male Candidates only.
• Strong understanding of Quality Assurance and validation processes
• Familiarity with ASME BPE standards and ISO guidelines
• Knowledge of qualification protocols (DQ, IQ, OQ)
• Ability to review and interpret technical documents and specifications
• Good coordination and communication skills
• Attention to detail and compliance-focused mindset
• Willingness to learn and work in a project-driven environment

Job Category: Quality Assurance

Job Type: Full Time

Job Location: Manufacturing Unit - Nelamangala