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QA Senior Specialist

4 months ago


Dublin, Dublin City, Ireland CPL Full time

Location:
Swords Campus

ABOUT US?


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 Pharmaceuticals Ingredients (APIs), Highly Potent Active Pharmaceuticals 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 at the Swords Campus seeks a QA Senior Specialist - Training Executive on a permanent contract.

Reporting to the QAS Manager, the QA Senior Specialist - Training Executive will cover day-to-day training administration tasks and support an overall process improvement project.


Position Description:

  • Learning Management System (LMS)

Management and Optimization:
Oversee the day-to-day operations of the SAP SuccessFactors LMS, ensuring the system runs smoothly and efficiently. Identify and implement improvements to streamline LMS processes and enhance user experience. Regularly update the LMS with changes to Standard Operating Procedures (SOPs), training requirements, and online assessments.

  • Data Analysis and Reporting: Create and distribute reports, including Training Needs Analysis, Training History, and adhoc reports as required. Analyse training data to identify trends, gaps, and opportunities for improvement. Generate compliance reports to ensure all training activities meet regulatory requirements (GMP, GDP, FDA, etc.).
  • Compliance and

Regulatory Adherence:
Ensure all training records and activities comply with GMP, GDP, FDA, and other relevant regulations. Prepare necessary documentation and respond to audit queries to support internal and external audits.

  • Record Management: Accurately enter and maintain training records in the LMS, ensuring timely updates and compliance. Update and manage changes to SOPs and training materials within the LMS.
  • Stakeholder Engagement and Support: Work closely with key stakeholders to identify opportunities for optimising LMS utilisation and training processes. Serve as the point of contact for LMSrelated queries, providing prompt and effective support.
  • Time Management and Efficiency: Efficiently manage multiple tasks and deadlines, ensuring timely completion of LMS updates and record maintenance. Identify and implement process improvements to enhance training record management and reporting efficiency.
  • Problem-Solving and

Issue Resolution:
Address and resolve LMS-related issues and queries promptly to minimise disruptions. Conduct root cause analysis for recurring issues and implement solutions to prevent future occurrences.

  • Communication and Collaboration: Communicate effectively with stakeholders to ensure clarity and alignment on training requirements and system updates. Organise all approved external training courses and, where necessary, raise the relevant purchase orders.
  • Continuous Improvement: Stay updated on LMS best practices and industry standards to improve system functionality and user experience continuously. Work on enhancing the training programs by leveraging LMS capabilities to deliver effective and engaging training experiences.

Required Competencies:

  • Learning Management System (LMS)

Proficiency:
In-depth knowledge of LMS platforms, particularly SAP SuccessFactors LMS. Ability to navigate, maintain, and optimise the system efficiently.

  • System Updates and Maintenance: Regularly update LMS with SOPs and training requirements changes to ensure it is current and reflects organisational needs.
  • Data Analysis and Reporting: Ability to generate, interpret, and present various reports such as Training Needs, Training History, and adhoc reports. Proficiency in data analysis tools and techniques.
  • Regulatory Knowledge: Familiarity with GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), FDA (Food and Drug Administration) requirements, and other relevant regulations to ensure compliance with training records.
  • Attention to Detail: Meticulous approach to entering and maintaining training records, ensuring accuracy and compliance.
  • Time Management: Efficiently manage multiple tasks and deadlines, particularly maintaining training records and updating LMS systems.
  • Document Management: Proficiency in updating and managing changes to Standard Operating Procedures (SOPs) and online assessments within the LMS.
  • Stakeholder Engagement: Ability to work closely with key stakeholders to identify and implement opportunities for optimisation and streamlining LMS utilisation.
  • Problemsolving: Ability to address and resolve LMSrelated issues and queries efficiently.
Why choose a career at SK biotek?

  • A chance to work with a world leader in contract development and manufacturing in a fast paced, dynamic and growing department.
  • Excellent opportunities for career enhancement and personal development.
  • Competitive base salary.
  • Annual bonus linked to base salary.
  • A wellestablished further education program.
  • Pension.
  • Private health insurance.