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Quality Assurance Specialist
1 month ago
We are seeking a skilled Quality Control Associate to join our team at BioTalent Search Private Limited. This role is based in Bengaluru and is responsible for ensuring that our In Vitro Diagnostics (IVD) products meet the required quality standards through testing, inspections, and compliance with regulatory guidelines (ISO 13485).
Key Responsibilities:
- Conduct and supervise routine and non-routine testing of raw materials, in-process materials, and finished products.
- Perform analytical and functional testing and validation of IVD products according to specifications and regulatory standards.
- Oversee environmental monitoring and sterility testing for controlled environments used in manufacturing.
- Maintain and calibrate laboratory equipment, ensuring compliance with calibration standards.
- Ensure timely documentation of QC results in compliance with Good Documentation Practices (GDP).
- Review and approve laboratory test results, identifying deviations or out-of-specification (OOS) results.
- Maintain QC records, batch release documentation, and Certificates of Analysis (CoA).
- Assist in the creation and revision of Standard Operating Procedures (SOPs) related to QC processes.
- Ensure compliance with ISO 13485 and other relevant standards for medical devices and IVD products.
- Participate in internal and external audits, ensuring adherence to regulatory and company-specific requirements.