Quality Documentation Specialist
2 weeks ago
Established in 2022, SK Pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities.
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.
Reporting to the QA Lead Specialist, you will be responsible for maintaining the document management system DCA (Document Control and Archiving).
Key Responsibilities- Maintain the document database from an administrative perspective.
- Issue working copies of Manufacturing Batch Records and Cleaning Batch Records.
- Undertake periodic reconciliation of all batch records.
- Prepare and issue logbooks to departments.
- Review SOPs, forms, etc. for compliance with good documentation practice.
- Main contact for archival and retrieval of all GMP documentation for site.
- Ensure completed GMP records are filed and archived as per procedures.
- Write procedures relevant to documentation management systems and document control.
This role requires excellent organisational and communication skills, along with a strong attention to detail and ability to multitask.
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