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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. Our mission is to ‘make what matters for a healthy, happier world’. The Swords Campus has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for almost 60 years. With a talented workforce and exceptional technical capabilities, we continue to make some of the world’s most important medicines.
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 of 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.
A continuous improvement mindset to change processes and systems is a distinct advantage.
The Quality Assurance Senior Specialist will be required to work on their own initiative as well as part of a team. 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 patients’ lives and we need you! By choosing a career with SK biotek Ireland, you'll join a team of passionate people working together to improve lives.
Other Benefits include:
* Excellent opportunities for career enhancement and personal development
* Annual bonus linked to business results
* A well-established further education program
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