Senior QA Expert in Pharmaceutical Quality Assurance
hace 5 días
Unlock a challenging career as a Senior QA Expert in Pharmaceutical Quality Assurance with Alk Abello Spa. About the Role
We are seeking an experienced Senior QA Specialist to join our team in Madrid, Spain. The successful candidate will be responsible for ensuring that our manufacturing, packaging operations, and product quality meet established cGMPs, guaranteeing lasting customer satisfaction.
Key Responsibilities:
- Perform Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, etc.
- Review GMP technical and validation reports related to 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, Provide 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: Fluid in the communications (both written and spoken) in English.
- Thorough knowledge in sterile products regulation.
- Oncological solutions experience is valuable.
- Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, 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 organisational complexity and ambiguity.
- Ideally experience in Medical Devices.
What We Offer:
- A competitive salary range of €70,000 - €90,000 per year, based on qualifications and experience.
- The opportunity to work with a global pharmaceutical company that helps people living with allergy.
- Access to cutting-edge technologies and innovative solutions.
- A collaborative and dynamic work environment with colleagues who share your passion for quality assurance.
- An attractive compensation package, including health insurance and retirement plan.
- A comprehensive training program to help you develop your skills and advance your career.
Location: Our site is located in Ciudad Lineal, Madrid, Spain, close to the center of the city and easily accessible by public transportation. We offer a flexible remote working policy to ensure work-life balance.
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