QA Lead Specialist- SK biotek Ireland

Website skbiotek SK biotek Ireland

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QA Lead Specialist


Location:   Swords Campus



SK biotek Ireland, an SK pharmteco company, 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 the wider SK Inc. with revenues of $88 billion in 2022. Our mission is to ‘make what matters for a healthy, happier world’, from grams to tonnes. The Swords Campus has led the way in the development, scale-up and commercial manufacture of Active Pharmaceutical Ingredients (APIs),  Highly Potent Active Pharmaceutical Ingredients and Chemical Intermediates for almost 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

Current Need:

The SK biotek Ireland Quality Team here at the Swords Campus are looking for a QA Lead Specialist on a permanent contract.

Position Description:

SK biotek Ireland is seeking to recruit a Quality Assurance Lead Specialist to join their QA Systems and Validation Team on a permanent basis. Reporting to the QA Systems and Validation Manger, the QA Lead Specialist will be responsible for managing and maintaining the sites documentation and quality management systems.

Responsibilities include but are not limited to:
• Managing the site computerised Documentation system, co-ordinating any configuration updates and escalating and resolving any technical issues in conjunction with IT.
• Ensure that controlled documents are managed in a timely and efficient manner according to procedure.
• Prepare and monitor the procedures necessary to operate an optimised document management system to best practice.
• Key point of contact for all local documentation procedures and initiatives.
• Ensure completed GMP batch records are filed and archived as per procedures and manage the relationship with the off-site storage vendor.
• Manage the recruitment, training and ongoing provision of the QA Administrator role in support of the document management system.
• Site SME and point of contact for all local Change Control procedures and initiatives.
• Act as Site Administrator for the Quality Management System (Trackwise).
• Responsibility for managing the Trackwise system, co-ordinating any configuration updates and escalating and resolving any technical issues in conjunction with IT.
• Compile monthly site quality metrics.
• Support customer and health authority Inspections.
• Actively contribute to continuous improvement initiatives including lean ways of working and the development and maintenance of metrics for trends and key performance indicators.
• Assessment of computer system changes for GMP compliance in accordance with the change control procedure for control systems.
• Review and approve control system Validation Master Plans, IQ and OQ protocols and reports.

The successful candidate will hold a BSc or BEng in Chemistry or a science related discipline, and should have a minimum of 5 years’ experience 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.
Experience in using and administrating Quality Management and Enterprise Systems is preferred but not required.
Knowledge of computer system validation and experience of approving VMP/IQ/OQ would be an advantage.

The QA Lead Specialist will be required to work on his/her own initiative as much as working as part of a team. As such excellent interaction, communication and presentation skills are necessary to be successful in the role.

Why choose a career at SK biotek?

A career with purpose and a chance to work with a world-leader in contract development and manufacturing in a fast-paced, dynamic, and growing organisation. Here at SK biotek Ireland, we believe we enhance patient’s lives and we need you! It reminds each one of us that what we do matters, and our mission is to ‘make what matters for a healthy, happier world’ – whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. By choosing a career with SK biotek Ireland, you’ll join a team of passionate people working together to improve lives by making what matters for a healthy, happier world.

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


Make a difference today! Suitable candidates should apply for this role by emailing your CV to

SK biotek is an equal opportunity and affirmative action employer

To apply for this job email your details to

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