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 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.
Job Description: QA Operations Specialist
This position is responsible for working closely with the business functions to provide QA Support.
The QA Operations Specialist will be working as part of the QA Operations team to ensure customer products are manufactured, stored and packaged in accordance with cGMP.
Key Responsibilities:
* 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.
Requirements:
* BSc or BEng in Chemistry or a science-related discipline.
* At least 1 year of 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 as a part of a team.
* Leading by example and exhibiting SK pharmteco values and behaviours.
* Excellent interaction, communication and presentation skills.
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.
SK pharmteco SM Europe is an equal opportunity employer.