Job Description
**Quality Assurance Specialist** Manage the registration process, internal audit program, and regulatory inspections to ensure compliance and quality oversight for manufacturing operations. **Responsibilities:** • Oversee the registration process and manage the internal audit program to ensure inspection readiness and identify improvements. • Lead regulatory inspections, develop remediation and CAPA plans, and ensure timely completion of commitments. • Manage external contract service provider and supplier audits, and ensure site regulatory compliance through effective change management and collaboration with the global regulatory affairs team. • Provide quality oversight for manufacturing operations, including batch records, deviations, and complaints, ensuring alignment with product registrations. • Support the deployment and maintenance of compliant, efficient quality systems aligned with risk management and commercial strategy. • Monitor regulatory changes and innovations, fostering a strong quality and compliance culture across the site. **Requirements:** • Bachelor's degree in Science or related field • At least 5 years experience in QA within a manufacturing environment • QP eligibility desirable but not essential **Skills:** • Quality assurance • Compliance • CAPA • Pharmaceuticals **Benefits:** • Work From Home