QA Senior Specialist
Permanent
Location: Swords, Co. Dublin, Ireland
About the company?
SK pharmteco 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 SK Inc., a Korea company with revenues of $99 billion in 2023. Our mission is to ‘produce and deliver life-changing therapies that improve patient outcomes and save lives’. The SK pharmteco Small Molecule, Europe, facility located in Swords, Co Dublin, Ireland has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 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 www.skpharmteco.com
Current Need:
The Quality Team here at the Swords Campus are looking for a QA Senior Specialist on a permanent contract.
Position Description:
- 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, 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.
- The Quality Assurance Senior Specialist will be required to work on their own initiative as much as working a part of a team. As such excellent interaction, communication and presentation skills are necessary to be successful in the role.
- The ideal candidate will lead by example and exhibit SK pharmteco values and behaviors.
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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