Senior QA Specialist

Job Purpose
This position 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.

Main Duties

• Provide quality support to technology transfer projects.
• 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
  • Provides on-site guidance in the preparation of procedures and working instructions.
  • Assists in providing resolution to GMP issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel
  • Helps 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

Candidate Requirements (competencies/work experiences)
The successful candidate will have knowledge, skills & experience gained in a pharmaceutical industry.

• 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.
• Fluid in the communications (both written and spoken) in English.
• Thorough knowledge in sterile products regulation, oral solids forms and technology transfer projects (mainly equipment qualification and process validation).
• 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 organisational complexity and ambiguity
• Ideally experience in Medical Devices

Important information
The position is based at ALK’s site in Madrid, located in the business area of Ciudad Lineal. We have a quick access to the Hermanos García Noblejas and Ascao metro stations and a wide bus connection network. The production site is located at Calle Miguel Fleta 19 while the Business Support area is next door, Santa Leonor 65, in a building called Avalon Business Park. Nevertheless, we have a remote working policy that will allow you to work from some days (you will receive ad-hoc information in the recruitment process).

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.