My client a leading Pharmaceutical company now require a QA Documentation Controller to join their expanding team. The QA Documentation Controller will take on responsibility for their area of work and to work independently following company SOPs. The role will primarily liaise and support the Manufacturing facility and supporting functions.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of QA Documentation Controller
- Manage the preparation, issue and control of GMP documents in the Document Management System (DMS) ensuring that required standards of presentation and formatting are consistently achieved. Good knowledge of Microsoft Word is required for this work.
- Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.
- Perform the Business System Administration role in the documentation management system.
- Ensure that all document training is carried out as required.
- Produce monthly key performance indicator (KPIs) on document control systems as required.
- Maintain document control software packages including; controlled documents database.
- Develop and maintain the document archiving system.
- Scan and photocopying of controlled documents.
- Provision of training to personnel and contract personnel as directed by the Quality Systems Executive
- Assist implementation of global standards and procedures into the site Quality Systems.
- To actively support the development/implementation and continuous improvement of the Document Management System and supporting systems.
- Provide support for regulatory submissions through collation and compilation of documents for inclusion in filings or presentation to auditors as required.
Requirements of QA Documentation Controller
- Bachelor's degree in chemistry, biology or a related scientific discipline.
- A minimum of 4 years working within quality in the pharmaceutical industry.
- Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
- Thorough understanding of quality systems and cGMP's.
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below