QA Senior Specialist

3 weeks ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

Cpl in partnership with SK biotek Ireland are looking for a Quality Assurance Senior Specialist on a permanent contract to join the Quality Team at the Swords Campus.

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 $88 billion in 2022. 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 Pharmaceutical Ingredients (APIs),Highly Potent Active Pharmaceutical 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:

The SK biotek Ireland Quality Team here at the Swords Campus are looking for a QA Senior Specialist on a permanent contract.

Position Description:

  • This is an onsite role working as part of the QA Quality team, site cross functional teams and customer teams to ensure that customer products are manufactured, stored and packaged in accordance with cGMP.
  • Review and approval of documentation associated with the manufacture of Commercial and New Investigational Products.
  • Review and approval of manufacturing and cleaning batch documentation and associated equipment logbooks in accordance with cGMP.
  • Responsible for the batch disposition of Commercial and New Investigational Products.
  • Participate in the preparation and review of procedures and batch documentation including process risk assessments.
  • Support the quality culture on site through actively supporting operations on the shop floor.
  • 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 Quality Assurance Senior Specialist will be required to work on their own initiative as much as working as a part of a team. As such excellent interaction, communication and presentation skills are necessary to be successful in the role.

Why choose a career at SK biotek?

A career with purpose and a chance to work with a world-leader in contract development and manufacturing in a fast-paced, dynamic, and growing organisation. Here at SK biotek Ireland, we believe we enhance patient's lives and we need you It reminds each one of us that what we do matters, and our mission is to 'make what matters for a healthy, happier world' - whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. By choosing a career with SK biotek Ireland, you'll join a team of passionate people working together to improve lives by making what matters for a healthy, happier world.

Other Benefits include:


• Excellent opportunities for career enhancement and personal development


• Competitive base salary


• Annual bonus linked to business results


• A well-established further education program


• Pension scheme


• Private Healthcare


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