Technical Document Writer required to join the Automation Team within a global Bio-pharmaceutical Organisation based in the picturesque Munster region of Ireland.
This role will be a site based position with some flexibility to work from home a couple of days per week; working from home flexibility to be agreed with Line Manager.
We are looking for someone with a
strong Compliance background within a GMP manufacturing environment for this role.
Essential Duties and Responsibilities include, but are not limited to the following:
- Responsibility for ensuring compliance with all aspects of Quality for the Automation team.
- Manage Deviations, CAPA, Change Control, Audits, and Quality risk management.
- Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
- Provides periodic reviews of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, preventative maintenance records/work orders, etc
- Responsible for the approval of deviation notification, driving deviation investigation and tracking implementation through to closure of associated corrective action.
- Responsible for generating and tracking Quality compliance metrics
- Responsible for generating and maintaining Life cycle document across automation platforms
Desired Experience:
- Experience working with validated Automation systems in the pharmaceutical manufacturing environment.
- Direct experience and in depth knowledge of automation platform desirable.
- Ability to work on own initiative, without direct supervision from management.
To be considered for this position, please apply with a copy of your up to date CV today!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
To view Quanta's privacy policy, please visit
our website
I manage this role.