JO-2410-542777
Document Control Specialist - NPI Projects
Reporting to the site Quality Assurance Manager
Midlands – Co Laois, commutable from Offaly, Kildare, North Tipperary and surrounds.
CPL are working with our client partner to hire aDocument Control Specialistfor their GMP certified chemical production facility in Laois. The plant has been purpose built to support their client portfolio, primarily in the Bio- Pharma, General Pharma and API manufacturing industries. Due to increased business, they require a Document Control Specialist to support a variety of commercialization/ NPI projects on-site
Role
* Responsible for document control of documents required for the Product Commercialization/NPI (new product introduction) process.
* Responsible for the management of the change control process for Product commercialization/NPI.
* Assist in the development of the process, review, and approval of all new and/or revised controlled documentation related to Product commercialization/NPI.
* Process documents for revision and approval, organize documents from conception to distribution and filing.
* Store, manage and maintain company documents while ensuring the accuracy and quality of them.
* Track and trend Change Control timeliness for the Product commercialization/NPI.
* Provide site training on technical writing practices
Requirements
* 1 -3 years previous experience in a similar role required.
* 1 -3 years’ experience in a regulated environment.
* Previous GMP experience preferred.
* A good team player, who can work well in cross functional teams.
* Strong written and oral communication skills.
* Strong negotiation skills
* Excellent attention to detail
* Proficient computer skills – Microsoft word, Excel, PowerPoint.
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