Quality Assurance Expert for Pharmaceutical Excellence
hace 15 horas
Company Overview: Alk Abello Spa is a leading global pharmaceutical company dedicated to delivering high-quality products that improve people's lives. Our mission is to provide innovative solutions for allergy sufferers worldwide.
Job Summary: We are seeking an experienced Quality Assurance Expert to join our team. As a Senior QA Specialist, you will play a vital role in ensuring the quality of our manufacturing processes, products, and facilities meet the highest standards of cGMPs.
Key Responsibilities:
- Perform Quality Assurance activities associated with maintaining internal Quality Systems, including Change control, Deviations, CAPA, etc.
- Review GMP technical and validation reports for Manufacturing and packaging processes, Computer/Automated systems involved in testing, manufacturing or materials control, Cleaning Validation/Equipment cleaning procedures, Laboratory and manufacturing equipment qualification, Facilities and Utilities with product contact, Analytical methods validation.
- Provide quality support to technology transfer projects, on-site guidance in the preparation of procedures and working instructions, assist in providing resolution to GMP issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel.
- Help support a permanent inspection readiness status, Provide QA support for regulatory filings, Prepare documentation for Material Review Board presentation and meetings, Support QA Management as required, Provide GMP quality expertise, advice and/or assistance across the organization as required.
Requirements:
- Minimum of 5 years' experience in the pharmaceutical/biotech industry and with a thorough knowledge of quality systems, GMP and regulatory requirements.
- University degree in Chemistry, Pharmacy, Biology or equivalent.
- Essential skill: Fluent in both written and spoken English.
- Thorough knowledge in sterile products regulation, Knowledge of oral solids forms and technology transfer projects is valuable.
- Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, and data integrity regulation.
- Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in stressful situations, can deal with organizational complexity and ambiguity.
Salary: $120,000 - $180,000 per year (dependent on experience)
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