ALK-Abelló A/S Spain

Quality Assurance Specialist / Qualified Person

 

 

Job Purpose:

This position will provide support for and be directly responsible for a range of Quality Assurance/Qualified Person 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

  • Review of batch records for accuracy and completeness
  • Review and approve all Master Batch Records used in manufacturing and packaging operations
  • Disposition and release of product manufactured and/or packaged on site or by 3rd Party Manufacturers & New Product Introduction Products
  • Collaborate in the execution of cGMP-training program.
  • Prepare and Participate in the GMP audit program (internal and supplier audits)
  • Approve and monitor suppliers
  • Homologation and evaluation of suppliers from quality perspective
  • Establish Quality Agreements with suppliers, as warranted and/or required by regulations
  • Review and approve all Master Batch Records used in manufacturing and packaging operations
  • Management of Change Control System.
  • Management of quality deviations.
  • Management of Customer Complaints
  • Review and Approval of Validations activities
  • Provide support to operational and functional groups to handle all situations that may adversely impact quality
  • Provide support to global projects as requested.
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Candidate Requirements (competencies/work experiences):

The successful candidate will have knowledge, skills & experience gained in a pharmaceutical industry. 

  • University degree in Pharmacy
  • Experience as Qualified Person
  • Minimum of 5 years’ experience in the pharmaceutical/biotech industry and with a thorough knowledge of quality systems, GMP and regulatory requirements including FDA.
  • 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

 

 

 

 Development Oportunities

 

Opportunities to work with a multidisciplinary team, coodinating a complex and wide list of relevant activities in a Manufacturing Company 

 

We offer

ALK 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.

 

Application deadline

30th October

 

Contact

For further information on the position please contact Leticia García, HR Development Consultant -  email lgjes@alk.net

 

Initiated by

11 September 2018, LGJES

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ALK is a global research-driven pharmaceutical company focusing on allergy prevention, diagnosis and treatment. We are the world’s leading company within allergy immunotherapy. We are constantly moving forward as we have maintained our pioneering spirit. We are large enough to offer you both challenges and good opportunities for development, but not large enough for you to disappear in the crowd.

 

We have experienced success and significant growth in recent years, and together with our international partners we work to expand the use of allergy immunotherapy worldwide. Therefore we need employees who both desire and are capable of influencing the company.

Compartir en:
Comunidad Autónoma:
Comunidad de Madrid
Plazo de solicitud:
11/09/2018
Fecha de inicio:
11/09/2018
Provincia:
Madrid
Contactos:
LETICIA GARCIA
Teléfono: +34 913276100
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