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Senior QA Specialist Madrid Spain,  

ALK-Abelló (company)

Posted on : 26 January 2017

Project Description

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 drug product contract manufacturing organizations (CMOs) 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
  • Perform external GMP and vendor qualification audits, risk assessments and write audit reports, and follow up on observation close-outs
  • Provide quality support to technology transfer projects.
  • Review GMP technical and validation reports
    • Analytical methods.
    • Laboratory and manufacturing equipment qualification where appropriate.
    • Manufacturing and packaging processes.
    • Computer/Automated systems involved in testing, manufacturing or materials control.
    • Equipment cleaning procedures.
    • Utilities with product contact.
    • Lead Continuous Quality improvement initiatives
    • 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
    • Perform Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, Product Complaint System, Annual Product Quality Reviews, GMP Training, etc.
    • 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. 
  • Ideally experience in Medical Devices and technology transfer
  • Minimum of 5 years  experience in the pharmaceutical/biotech industry and with a thorough knowledge of quality systems, GMP and regulatory requirements including FDA.
  • University degree in Chemistry, Pharmacy, Biology or equivalent.
  • Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, sterile operations,  cGMPs, regulatory issues
  • 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
  • Fluid in the communications (both written and spoken) in English
  • Experience working with Contract Manufacturers preferred

We offer
  • Our company provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. 
  • The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo.
  •  Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process.
  •  You will be part of an engaged and informal team who values skill and knowledge creation. 
  • The job is very flexible and you have very much influence on your daily work.



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