Senior QA Specialist (High proficiency in English) Are you passionate about working in a global pharmaceutical company that helps people living with allergy? Are you motivated to make improvements, leading to better economy, quality and social responsibility? Are you perceived as a structured and constructive person with excellent collaboration skills?
As a Senior QA Specialist (High proficiency in English) , you will provide support for and be directly responsible for a range of Quality Assurance functions. This position will contribute to ensure that performance of manufacturing, packaging operations and product quality conforms to established cGMPs to ensure lasting customer satisfaction. This individual will demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented.
Reports to: Quality Support Manager
Fields of responsibility
Perform Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, etc.
Review GMP technical and validation reports:
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.
Minimum 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 communications (both written and spoken) in English.
Thorough knowledge in sterile products regulation.
Oral solids forms and technology transfer projects knowledge 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.
The company
By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience and almost 3,000 employees around the world, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life.
We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.
We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with colleagues.
The position is located at ALK's site in Madrid, in the business area of Ciudad Lineal, very close to the center of Madrid. We have quick access to the Hermanos García Noblejas and Ascao metro stations and we also have a wide bus connection. The manufacturing center is located at Calle Miguel Fleta 19 while the Business Support area is in an annex building located in the Avalon Business Park. Nevertheless, we have a remote working policy that will allow you to work from home part of your time.
ALK, among other benefits, has a canteen where employees can have breakfast and lunch every day.
If this sounds like a company mission, job, and a department you would like to be part of, we hope to receive your CV and application, but please do not send your CV via e-mail due to GDPR rules.
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