QA/qc Incharge

12 hours ago

Savli Vadodara Gujarat, India Shah Brothers Full time

The QA/QC Incharge is responsible for implementing and monitoring quality assurance and quality control activities in the manufacturing of biopharma fluid handling components such as pumps, valves, tubing, hoses, and cleanroom-grade assemblies. This role ensures all materials, processes, and finished goods meet internal quality standards and external regulatory requirements (cGMP, ISO 13485, ASME BPE, etc.), while supporting continuous improvement initiatives across the production cycle
- Perform routine Environmental Monitoring activities: viable and non-viable monitoring, surface monitoring, personnel monitoring.
- Good knowledge of cleanroom classification (ISO 14644), Good Manufacturing P and EM requirements
- Ability to prepare and execute validation protocols and summarize reports
- Skilled in microbial monitoring techniques and aseptic area behaviour.
- Strong documentation, audit readiness, and data integrity practices
- Good knowledge of cleanroom classification (ISO 14644), Good Manufacturing P and EM requirements

**EDUCATION REQUIRED**:

- Bachelors or masters Degree/Biotechnology, Microbiology or related field.
- 1-5 years of experience in QA/QC in the biopharma equipment, medical devices, or cleanroom-related manufacturing industry.
- Familiarity with GMP, ISO 13485, ASME BPE standards, and cleanroom protocols is highly preferred.

**Job Types**: Full-time, Permanent

Pay: ₹233,171.30 - ₹500,000.00 per year

**Benefits**:

- Health insurance
- Provident Fund

Work Location: In person

Expected Start Date: 15/10/2025

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