QA Systems Administrator

2 days ago

Dublin, Dublin City, Ireland Cpl Healthcare Full time

Cpl in partnership SK biotek Ireland is seeking to recruit aQA Systems Administrator for 12 months contract.

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 athttps://vimeo.com/skpharmteco.

Current Need:

The SK Biotek Ireland Quality Systems team at the Swords Campus are looking for a QA Systems Administrator reporting to the QA Lead Specialist.

Position Description:

The successful candidate will be responsible for maintaining the document management system DCA (Document Control and Archiving) and for liaising with cross-functional departments on documentation requests and issues.

Operational Duties

  1. Maintain the document database (DCA) from an administrative perspective.
  2. Issue working copies of Manufacturing Batch Records and Cleaning Batch Records.
  3. Undertake periodic reconciliation of all batch records.
  4. Prepare and issue logbooks to departments.
  5. Review of SOPs, forms, etc. for compliance with good documentation practice.
  6. Main contact for archival and retrieval of all GMP documentation for site, includes liaising with archival vendor.
  7. Ensure completed GMP records are filed and archived as per procedures.
  8. Write procedures relevant to documentation management systems and document control.
  9. Administrative activities to support operation of the Quality department.

Change Control

  1. Initial Quality assessment of Change Controls.
  2. Change control planning meeting back-up.

Manage information

  1. Provide document periodic review data and follow-up.
  2. Provide training on Document Management System and procedures.
  3. Manage documentation trackers with respect to Batch Record and logbook issue and reconciliation.

Manage People/Interactions with People

  1. Liaise with all departments to ensure that documents are controlled consistently.
  2. Provide training to staff from different functions on document management procedures as required.
  3. Communicate document or DCA related issues.
  4. Communicate status of documents when requested.

Minimum Requirements

  1. 1 years' experience in an administrative role in a Pharmaceutical environment.
  2. Experience with DCA DMS or TrackWise QMS is a plus.

Skills:

  1. Highly motivated.
  2. Good time management and organisational skills.
  3. Ability to multi-task.
  4. Ability to work with initiative.
  5. Flexibility to react to changing business needs.
  6. Good interpersonal skills.
  7. Good communication and presentation skills.
  8. Working knowledge of GMP.
  9. Excellent PC skills, MS Word, Excel, PowerPoint, Email and Calendar.
  10. Aptitude for electronic systems.
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