GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services (CQV) to the life sciences and technology sectors. We partner with many of the world’s largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all important activities meet both current requirements and client’s needs.
We are hiring for Document Specialists for the Sligo region.
- Develop and update training plans for the training of Operations Personnel in the Biologics facility
- Documentation of all activities in line with cGMP requirements.
- Develop and modify procedures as needed to support the manufacturing operation.
- To work as a team member to support biologics operations in line with all safety, regulatory and organizational requirements.
- To support the Operations Lead in line with safety, regulatory and organisational requirements when delegated responsibility.
- Interface with vendor to ensure that equipment/facility designs are aligned and to ensure efficient transfer of information between vendor and site
- Liaising with engineering, quality and S&T to ensure equipment and process performance is maximized.
- Provide support on change controls, investigations, tasks and CAPAs for the Biologics Operations Department.
- Understands the impact of equipment control systems on processing performance
Education & Key Requirements
- Certificate or Higher in a relevant Science/ Engineering / Manufacturing discipline.
- Proven technical, interpersonal & communication skills both verbal and written.
- Experience or aptitude in managing projects.
- Requires innovative thinking and a high level of attention to detail.
- Excellent knowledge of relevant GMPs, regulations and current industry trends.