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Life Sciences and Healthcare Quality Assurance Specialist
3 weeks ago
We are seeking a highly skilled Quality Assurance Manager to join our team. This role is responsible for ensuring quality excellence, compliance with industry regulations, and delivering customer satisfaction in the life sciences and healthcare sector.
Key Responsibilities- Manage regulatory compliance and ensure adherence to Good Manufacturing Practice (GMP) and Good Distribution Practices (GDP) standards.
- Establish and maintain quality management systems that meet ISO 13485 requirements.
- Coordinate with clients and relevant functions for timely Field Safety Corrective Action (FSCA) reporting to local health authorities.
- Develop and implement quality standard operating procedures (SOPs) and work instructions (WI) to support regulatory and industry requirements.
- Qualify warehouse facilities and equipment, including temperature mapping and qualification of instruments and software.
- Support risk assessments and investigate deviations from standard procedures.
- Track and report on quality-related key performance indicators (KPIs).
- Possess a degree in science or other relevant fields.
- Minimum 5 years of experience managing quality management systems and compliance in operational life sciences and healthcare environments.
- Demonstrable experience managing quality systems and compliance to GMP, GDP, and ISO 13485 standards.
- Proven leadership and problem-solving skills.
