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QA Ops Specialist Support NPI

1 month ago

Dublin, Dublin City, Ireland Cpl Full time

QA Ops Specialist Support NPI (onsite role)

Cpl in partnership with SK biotek Ireland are looking for a QA Operations Specialist supporting New Product Introduction activities on a 12 month contract at the Swords Campus.

ABOUT US?

SK biotek Ireland, an SK pharmteco company, is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of the wider SK Inc. with revenues of $95 billion in 2020. Our mission is to 'make what matters for a healthy, happier world', from grams to tonnes. The Swords Campus has led the way in the development, scale-up and commercial manufacture of Active Pharmaceuticals Ingredients (APIs), Highly Potent Active Pharmaceuticals Ingredients and Chemical Intermediates for almost 60 years. With a talented workforce, exceptional technical capabilities, and facilities we have made some of the world's most important medicines and continue to do so. Further information on SK pharmteco can be found at

Current Need:

Cpl in partnership with SK biotek Ireland are looking for a QA Operations Specialist Support NPI on a 12 month contract within the Quality Team at the Swords Campus.

Position Description:

This is an onsite role working as part of the QA Operations team, supporting the review and disposition of manufactured products, customer documentation, New Product Introductions and ad hoc support of capital projects to ensure that customer products are manufactured, stored and packaged in accordance with cGMP.

Actively contribute to continuous improvement initiatives including lean ways of working and the development and maintenance of metrics and trends and key performance indicators.

Minimum Requirements:


• The successful candidate will hold a BSc or BEng in Chemistry or a science-related discipline, and should have at least 3 years pharmaceutical experience ideally in a QA role.


• The successful role holder will be able to demonstrate excellent time management and organizational skills along with a proven ability to multi-task.


• Continuous improvement mindset to change processes and systems a distinct advantage


• The QA Operations Specialist Support NPI will be required to work on their own initiative as much as working as part of a team. As such excellent interaction, communication and presentation skills are necessary to be successful in the role.

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