Job Reference: FRS49578
Job Duration:
Start date: ASAP
Description:
Quality Systems Documentation Specialist Cork
Our prestigious and established pharmaceutical client in Cork are seeking to recruit a QS Documentation Specialist to join their busy team. Our client work within a niche sector and have a reputation of excellence within their field.
Prior experience of working in a document managementor related role is essential for this Documentation Specialist job.
Key Responsibilities:
* Carries out tasks related tothe management of Document Control and Records Management
* Provide guidance on the site document control and records management procedures and policies.
* Reviews received documents for conformance to site systems in respect of EDMS and GDP requirements.
* Liaises with document owners in respect of approval schedules and implementation of new or revised documents.
* Provides feedback from document review to the document owners.
* Carries out administration of the Electronic Document Management System at the site.
* Develops and applies systems and procedures related to the EDMS at the site.
* Develops and implementsprocesses, procedures and tools related to the implementation of compliance systems at the site.
* Coordinates the Records Management Policy for the site and carries out asks related to the storage and archiving of GMP documents.
* Provides training in Good Documentation Practice (GDP) and GMP to site personnel.
* Develops and maintains training materials for provision of GDP and GMP training to site personnel.
* Supports Inspection readiness at the site as documentation and Records Management SME.Qualifications:
* Third level qualification in a scientific/technical discipline required.
* A minimum of 2 years' experience in a document management or related role within the biological and/or pharmaceutical or medical device industry.* Knowledgeable of FDA/HPRA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals/Medical Device.
* Experience in development and / or evolution of GMP systems and/or start up experience highly desirable.
In addition to a very attractive salary and good company benefits, our client offers a superb working environment, and the chance to develop a long-term career within a growing pharma company.
Please contact Eoin on 086 7834955 for further information about this QS documentation specialist job.
Industry: Pharmaceuticals
Salary: DOE
Salary Benefits: DOE
Vacancy Type: Permanent
Job Skills: Data Management, GDP, EDMS, Data entry
Contact Name: Eoin Looney
Website: -
Direct Application URL: -