Senior Quality Assurance Expert
hace 3 semanas
**Job Description:**
Alk Abello Spa seeks a highly skilled Senior QA Specialist to support and lead various Quality Assurance functions. This role will contribute to ensuring the quality of manufacturing, packaging operations, and products conform to established cGMPs, guaranteeing lasting customer satisfaction.
**Responsibilities:**
- Maintain internal Quality Systems, including Change Control, Deviations, CAPA, etc.
- Review GMP technical and validation reports for manufacturing and packaging processes, computer/automated systems, cleaning procedures, laboratory and manufacturing equipment qualification, facilities and utilities with product contact, and analytical methods validation.
- Provide quality support to technology transfer projects and offer on-site guidance in preparing procedures and working instructions.
- Identify problem areas, refine systems, train and coach relevant personnel, and provide resolution to GMP issues.
- Support a permanent inspection readiness status and assist in regulatory filings preparation.
**Requirements:**
- Minimum 5 years' experience in the pharmaceutical/biotech industry, with thorough knowledge of quality systems, GMP, and regulatory requirements.
- University degree in Chemistry, Pharmacy, Biology, or equivalent.
- Fluent written and spoken English, with thorough knowledge in sterile products regulation.
- Expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, and data integrity regulation.
- Strong interpersonal and leadership skills for dealing with diverse cultures, organizational complexity, and ambiguity.
**Estimated Salary:** $80,000 - $110,000 per year (dependent on location and experience).
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