QA Documentation Controller is required for a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long term market support. The team on site grow, purify, formulate and bulk fill mammalian cell culture derived APIs for medicines intended for human use. The site is currently moving from commissioning into full scale commercial operations. This is an opportunity to work in a company that is innovative (ranked 10th most innovative by Forbes) and recognized globally as one of the fastest companies to get medicines to market.
The QA Documentation Controller will:
o Oversee all aspects related to controlled document mastering, issuance, distribution and storage in a GxP environment, including Commercial and Clinical batch records, SOPs and forms.
o Maintain technical agreements with external service providers.
o Perform routine internal audits to ensure compliance and continued process improvement.
o Represent QADV systems in regulatory and partnership audits.
o Oversee employee training on GDP and the electronic document system.
o Participate in internal and external compliance audits as related to QADC activities.
o Coordinate periodic routine reviews of controlled documents.
The QA Documentation Controller will require:
o Bachelor of Sciences (BSc) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
o 5+ years experience in a cGMP regulated manufacturing environment with exhibited knowledge or proficiency in Document control and related systems
o Good knowledge and understanding of GMP requirements and guidelines
o Proficiency with technical summary report generation required, with exceptional organizational and Computer skills preferred.
Call Amparo in LSC on 0214777 329 to discuss this QA Documentation Controller role in more detail or apply directly via this advert