Quality Assurance Specialist

1 day ago

Amrāvati, Maharashtra, India beBeeRegulatory Full time ₹ 2,40,00,000 - ₹ 4,00,00,000
Quality Assurance Manager

The Quality Assurance Manager is responsible for ensuring compliance with regulatory standards related to quality, packaging, labeling, storage, and distribution of surgical disposable products.

Main Responsibilities
  1. Ensure Quality Management System (QMS) compliance with ISO 13485, ZED, and GMP standards by conducting regular audits and implementing corrective actions as necessary.
  2. Review and approve batch records, SOPs, and quality documents to ensure accuracy and adherence to regulations.
  3. Oversee product packaging, labeling, testing, and release for dispatch to guarantee customer satisfaction and maintain a high-quality product portfolio.
  4. Investigate and manage deviations, complaints, CAPAs, and change controls in a timely and efficient manner to minimize their impact on production.
  5. Monitor warehouse conditions, equipment calibrations, and validation records to ensure a safe and controlled environment for storage and processing.
  6. Coordinate internal and external audits, inspections, and supplier evaluations to identify areas for improvement and optimize business processes.
  7. Ensure timely product testing and maintain ETO batch records to support regulatory submissions and customer requirements.
  8. Conduct training sessions on quality procedures as per schedule to educate employees on best practices and regulatory requirements.
Qualifications and Skills
  • Bachelor's or Master's degree in Science, Pharmacy, or a related field with relevant work experience in Quality Assurance within the medical device or pharmaceutical industry.
  • Strong knowledge of ISO 13485, GMP, and regulatory compliance principles with ability to apply them in a real-world setting.
  • Excellent documentation, auditing, and communication skills with ability to present complex information in a clear and concise manner.

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