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CPL in partnership with SK biotek Ireland is seeking to recruit a QA Systems Administrator for a 12-month 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 SK Inc., with revenues of $88 billion. Our mission is to ‘make what matters for a healthy, happier world’, from grams to tonnes. The Swords Campus has led 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 produced some of the world’s most important medicines. Further information on SK Pharmteco can be found at.
Current Need:
The SK Biotek Ireland Quality Systems team at the Swords Campus is 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 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 SOPs, forms, etc., for compliance with good documentation practices.
6. Be the main contact for archival and retrieval of all GMP documentation for the site, including liaising with the 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. Perform administrative activities to support the operation of the Quality department.
Change Control:
* Conduct initial Quality assessments of Change Controls.
Manage Information:
* Provide document periodic review data and follow-up.
* Provide training on Document Management System and procedures.
* Manage documentation trackers related to Batch Record and logbook issue and reconciliation.
Manage People/Interactions with People:
* Liaise with all departments to ensure consistent document control.
* Provide training to staff from different functions on document management procedures as required.
* Communicate document or DCA-related issues.
* Communicate status of documents when requested.
* Minimum 1 year of experience in an administrative role in a pharmaceutical environment.
* Experience with DCA, DMS, or TrackWise QMS is a plus.
Skills:
* Highly motivated.
* Good time management and organisational skills.
* Ability to multi-task.
* Ability to work with initiative.
* Flexibility to adapt to changing business needs.
* Good interpersonal skills.
* Good communication and presentation skills.
* Working knowledge of GMP.
* Excellent PC skills, including MS Word, Excel, PowerPoint, Email, and Calendar.
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