Job Description:
CPL, in partnership with SK pharmteco, is hiring a permanent QA Operations Specialist to join the team at our North Dublin site in Swords.
About Us
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 Korean company with revenues of $99 billion. 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.
Current Need:
The Quality Team at the Swords Campus are looking for a Quality Assurance Operations Specialist reporting into the QA Team Lead. The QA Operations Specialist will be working closely with the business functions to provide QA Support.
Position Description:
* Working as part of the QA Operations team 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 1 year of pharmaceutical experience, ideally in a QA role.
* The successful role holder will be able to demonstrate excellent time management and organisational skills along with a proven ability to multi-task.
* The Quality Assurance Specialist will be required to work on their own initiative as much as working as a part of a team.
* Leading by example and exhibiting SK pharmteco values and behaviours.
* Excellent interaction, communication, and presentation skills are necessary to be successful in the role.
Other Benefits:
* 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.