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 a Document Control Specialist for 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.
