Quality Assurance Senior Specialist
We are seeking a Quality Assurance Senior Specialist to join our Quality Department based in Swords, Co. Dublin on a permanent basis.
About SK pharmteco
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 significant revenue. 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 here at the Swords Campus are looking for a Quality Assurance Senior Specialist on a permanent contract.
Position Description
As a Quality Assurance Senior Specialist, you will:
* Work with the QA Quality team, site cross-functional teams and customer teams to ensure customer products are manufactured, stored and packaged in accordance with cGMP.
* Review and approve documentation associated with the manufacture of Commercial and New Investigational Products.
* Review and approve manufacturing and cleaning batch documentation and associated equipment logbooks in accordance with cGMP.
* Be 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
To be successful as a Quality Assurance Senior Specialist, you will need:
* A BSc or BEng in Chemistry or a science-related discipline.
* At least 3 years pharmaceutical experience, ideally in a QA role.
* Excellent time management and organizational skills along with a proven ability to multi-task.
* Ability to work on their own initiative as much as working part of a team.
* Excellent interaction, communication and presentation skills.
Other Benefits
In addition to a competitive salary, you will also receive:
* Excellent opportunities for career enhancement and personal development.
* An annual bonus linked to business results.
* A well-established further education program.
* A pension scheme.
* Private Healthcare.