Quality Assurance Expert for Pharmaceutical Operations
hace 2 semanas
**Company Overview**
Alk Abello Spa, a global pharmaceutical company, aims to simplify allergy management by providing trusted solutions. Our team is passionate about delivering high-quality products that meet customer needs.
**Salary:** $80,000 - $120,000 per annum, depending on experience and qualifications.
**Job Description**
We seek a highly skilled Senior QA Specialist with expertise in quality systems, GMPs, and regulatory requirements. As a key member of our team, you will be responsible for ensuring the quality and integrity of our products, collaborating with cross-functional teams, and driving continuous improvement initiatives.
**Responsibilities:**
- Maintain internal Quality Systems, including change control, deviations, CAPA, and quality metrics.
- Review technical reports on manufacturing processes, computer systems, cleaning validation, laboratory equipment, and facilities.
- Provide quality support to technology transfer projects, preparation of procedures, and working instructions.
- Identify problem areas, refine systems, train personnel, and assist in resolving GMP issues.
- Support permanent inspection readiness status, regulatory filings, and Material Review Board presentations.
**Requirements:**
- Minimum 5 years' experience in pharmaceutical/biotech industry, with thorough knowledge of quality systems, GMPs, and regulatory requirements.
- University degree in Chemistry, Pharmacy, Biology, or equivalent.
- Fluent written and spoken English, as well as knowledge of sterile products regulation.
**Benefits:** Competitive salary, comprehensive benefits package, opportunities for professional growth, and collaboration with a dedicated team.
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