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.'
Job Description: QA Lead Specialist
The Quality Team at the Swords Campus is seeking a Quality Assurance Lead Specialist on a 12-month contract.
Key Responsibilities:
* Oversee critical quality activities including New Product Introduction and Capital projects.
* Maintain key quality systems and lead process validation studies.
* Serve as the main point of contact from QA with customers.
* Manage a portfolio of customer quality activities.
* Ensure adherence to Annual Product Review schedules.
* Participate in audits by regulatory agencies and customers.
Requirements:
* Bachelor's or Master's degree in Chemistry or a related scientific field.
* Minimum of 10 years of experience in the pharmaceutical industry, preferably in a Quality Assurance role.
* Strong initiative and ability to work independently and collaboratively within a team.
* Proficiency in API manufacturing from NPI through to commercialisation.
* In-depth knowledge of cGMP principles relevant to API manufacturing.
* Knowledge of regulatory requirements, trends, hot topics and emerging requirements.
* Strong awareness of the CDMO business environment and financial acumen.
Desired/Advantageous Skills:
* Customer Services
* Project Management
* Lean Six Sigma
* QRM