QA Lead Specialist- Ireland

3 weeks ago

Dublin, Dublin City, Ireland SK biotek Full time

About Us

SK Biotek Ireland, a company under SK Pharmteco, is a global Contract Development and Manufacturing Organization (CDMO) with cutting-edge facilities in Korea, US, France, and Ireland. As part of the broader SK Inc. entity with revenues of $88 billion, our goal is to meet customer needs from small to large scale. The Swords Campus has been a pioneer in developing, scaling up, and producing Active Pharmaceutical Ingredients (APIs), Highly Potent Active Pharmaceutical Ingredients, and Chemical Intermediates for nearly six decades. With a skilled workforce, exceptional technical capabilities, and top-notch facilities, we have manufactured some of the world's most crucial medicines and continue to do so. More details about SK Pharmteco can be found on their official website.

Current Need

The Quality Team at SK Biotek Ireland, located at the Swords Campus, is in search of a QA Lead Specialist for a permanent position.

Position Description

SK Biotek Ireland is looking to hire a Quality Assurance Lead Specialist to join their QA Systems and Validation Team on a permanent basis. Reporting to the QA Systems and Validation Manager, the QA Lead Specialist will oversee the management and upkeep of the site's documentation and quality management systems.

Responsibilities include but are not limited to:

• Managing the site's computerized Documentation system, coordinating configuration updates, and resolving technical issues in collaboration with IT.

• Ensuring controlled documents are handled promptly and efficiently as per procedures.

• Preparing and monitoring procedures to maintain an optimized document management system following best practices.

• Serving as the main contact for all local documentation procedures and initiatives.

• Managing the filing and archiving of completed GMP batch records according to procedures and handling the relationship with the off-site storage vendor.

• Supervising the recruitment, training, and ongoing support of the QA Administrator role for the document management system.

• Acting as the Site SME and contact point for all local Change Control procedures and initiatives.

• Serving as the Site Administrator for the Quality Management System (Trackwise).

• Overseeing the Trackwise system, coordinating configuration updates, and addressing technical issues with IT.

• Compiling monthly site quality metrics.

• Supporting customer and health authority inspections.

• Contributing actively to continuous improvement initiatives, including adopting lean work methods and establishing and managing metrics for trends and key performance indicators.

• Assessing computer system changes for GMP compliance in line with the change control procedure for control systems.

• Reviewing and approving Validation Master Plans, IQ, and OQ protocols and reports for control systems.

The ideal candidate should have a BSc or BEng in Chemistry or related scientific discipline, with a minimum of 5 years' experience in a QA role. Strong time management and organizational skills, along with the ability to multitask, are essential. While experience with Quality Management and Enterprise Systems is preferred, it is not mandatory. Knowledge of computer system validation and experience in approving VMP/IQ/OQ would be beneficial.

The QA Lead Specialist must be capable of working independently as well as part of a team. Therefore, excellent interaction, communication, and presentation skills are vital for success in this role.

Why Choose a Career at SK Biotek?

Joining SK Biotek offers you a purpose-driven career opportunity to collaborate with a world-leading contract development and manufacturing company in a rapidly evolving and dynamic organization. At SK Biotek Ireland, we are dedicated to improving patients' lives, and we value your contribution. Our mission is to create meaningful impact for a healthier, happier world. Regardless of your position, you play a crucial role in a chain of events that positively influences millions worldwide. By joining SK Biotek Ireland, you become part of a passionate team committed to enhancing lives and creating a healthier, happier world.

Other Benefits Include:

  • Excellent opportunities for career advancement and personal growth
  • Competitive base salary
  • Annual bonus tied to business performance
  • Established further education program
  • Pension scheme
  • Private Healthcare

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