Experience
1 - 3 yrs
Job Location
Bengaluru, India
Vacancy
1
Designation
Quality Associate
Job Type
Not specified
Job Description
Job Title: Associate – Quality
Job Summary :The Associate – Quality is responsible for ensuring product quality, process compliance, and adherence to cleanroom and regulatory standards across the area. The role involves in-process quality checks, raw material inspection, testing, documentation control, calibration coordination, and support for quality system compliance.
Key Responsibilities:
- Daily Monitoring & Reporting Maintain and update daily monitoring records for: o Differential Pressure (DP) o Temperature & Humidity o Freezer conditions o Weighing balance verification Ensure all environmental and equipment parameters remain within specified limits.
- Quality Control Issue batch records as per the approved production plan. Provide line clearance prior to production startup. Ensure production is as per the approved drawing and with approved PO quantity. Perform dimensional and visual inspections including: Approve first-off samples for products. Ensure proper product sealing and compliance with specifications. Perform Tensile test and integrity test.
- Dispatch Quality Inspection Inspect dispatch materials for: o Certificate of Compliance (COC) o Quantity verification o Label accuracy o Packaging integrity and condition Approve final inspection status and apply green release stickers
- Incoming material Approval Inspect incoming materials as per SOP requirements. Verify packaging condition and supporting documentation. Approve materials only after confirming compliance with quality standards.
- Yield & Rejection Tracking Maintain daily rejection reports in the yield tracking system. Monitor rejection trends and support corrective actions for quality improvement
- Training & Development Train new employees on: o Cleanroom practices o Safety procedures o 5S principles o Defect identification o Production line clearance o Production process checks o Batch record documentation o Packing inspection procedures
- Calibration Management Ensure timely calibration and preventive maintenance (PM) of equipment. Monitor calibration schedules and maintain accurate records.
- Batch Process Review Review batch production records for: o Accuracy o Completeness o Compliance with specifications and procedures
- Documentation & Compliance Maintain document control and record management systems. Ensure batch records are completed contemporaneously and accurately. Maintain audit-ready documentation with full traceability.
- Cleanroom Compliance Monitor cleanroom conditions and contamination control practices. Ensure adherence to cleanroom procedures and protocols.
- Material Storage & Handling Ensure proper storage and handling conditions for all materials. Prevent contamination, mix-ups, and material damage.
- Quality System Compliance Ensure adherence to SOPs, regulatory requirements, GMP standards, and internal quality systems. Support internal and external audits and inspections.
Preferred Skills & Competencies: Knowledge of GMP, SOPs, and cleanroom practices Understanding of Quality Management Systems (QMS) Experience in dimensional and physical testing Strong documentation and reporting skills Attention to detail and quality-focused mindset Familiarity with calibration and compliance requirements
Preferred Qualification: Diploma / Bachelor’s Degree in Engineering, Biotechnology, Science or related field
Experience: 1–3 years of experience in Quality Assurance or Quality Control within manufacturing, medical devices, or cleanroom environments preferred.
No Referrers Available
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