QA Documentation Specialist required for a market leading, top Ten Biopharmaceutical company based in Cork. The Cork campus specialises in Tabletting, Solid Dose, Packaging & Distribution of a range of products. The site is a strategically important site within their global operations and has grown consistently since its founding almost 15 years ago. Today the site is responsible for Tablet manufacturing, quality control, packaging, and the release and distribution of the company’s products in the EU and other international locations. The Cork campus is a team focused organisation, who work to ensure their medicines are delivered on time and to the highest possible quality.
In this new position the QA Documentation Specialist will:
o Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
o Assists with the maintenance of programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).
o Participates in developing of & revision to QA documents (including Standard Operating Procedures, Work Instructions etc) to ensure that quality objectives are met and also for continuous improvement of Quality Systems.
o Provides clerical and administrative support related to both the site GTrack & GDocs Systems.
o Responsible for filing and maintenance of Quality Systems related documents.
o Aids in the provision of Level 1 GDocs & GTrack SPARC request/ query support for GSIUC.
o Provides QA Document Co-ordinator support for the site Artwork Process.
o Participates in cross site teams as the GSIUC representative – Attending associated meetings, ensuring GSIUC is represented & it’s concerns/ issues communicated, aiding in the identification of potential improvements and participating in discussions on issues/ queries on the associated systems/ process.
The QA Documentation Specialist will require:
o Experience with Agile, EBS or MES systems would be an advantage.
o Demonstrates basic knowledge of organizing, filing, scanning of documents and records.
o Demonstrates entry level knowledge of current Good Manufacturing Practices (GMPs).
o Demonstrates entry-level proficiency in Microsoft Office applications.
Contact Mairead at LSC on 021 4777 329 for more details, or apply directly via this advert.