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Mylan

QA Manager/QP Respiratory R&D

Mylan

  • Dublin
  • Not disclosed
  • Not disclosed
  • Updated 05/04/2013
  • HR
this job is expired
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Description

QA Manager/QP Mylan Global Respiratory Group

 

Mylan Global Respiratory Group is building a team at our new facility in Dublin,Ireland, that will be responsible for pilot scale manufacturing, analytical testing and quality assurance of new inhalation drug products. The team will be part of our R&D group with close links to commercial manufacturing.

 SCOPE OF THE ROLE:  To manage and lead the Pilot Plant site Quality Assurance Team, leading the construction and maintenance of the Quality Management System.  This role will act as the primary site QP and assume full responsibility of the release function in line with EU directives for the certification of clinical materials.  The individual will act as the subject matter expert with respect to the IMB and FDA along with providing QP support and guidance to business lines with a focus on drug product clinical supply manufacturing, assembly, testing, release operations, commissioning, qualification and process development. The position will have overall responsibility for internal and external audits, the vendor management programme and the oversight of the training system. 

 

EDUCATION AND TRAINING:

  •  Educated to degree level and/or 10 years plus experience in pharmaceutical QA/QP roles.
  • Demonstrated previous QP positions.
  • Have had previous experience of external influence in the pharmaceutical industry including front line regulatory interaction.

 

OTHER REQUIREMENTS

  •  Capable of forming strong professional relationships across all functional lines and gain the respect of those in partner lines.
  • Strong leader and able to work well under pressure.
  • Professional in conduct.
  • Willing to expand knowledge base and learn and then implement the new learning.
  • Efficient and well organised in work execution practices.

Ref: Resp QA Mgr/QP -
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Mylan

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