TECHNICAL WRITERS (AUTOMATION COMPLIANCE) required by CareerWise Recruitment for our multinational BioTech client in Limerick. Two contract positions available.
The TECHNICAL WRITER (AUTOMATION COMPLIANCE) will have responsibility for ensuring compliance with all aspects of Quality for Automation and will have a minimum of 5 years' experience working with validated Automation systems in the pharmaceutical manufacturing environment.
Role of this position
- 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.
- Maintaining electronic systems used for change control and deviation management.
- 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.
- Coordinate Compliance activities with and seek team support from QA, Validation Engineering and Manufacturing.
- Responsible for generating and maintaining Life cycle document across automation platforms.
- Ensure consistency by provide guidance and direction in the preparation of all Compliance/Validation documents.
- Liaise with QA to provide accurate and efficient communication ensuring clarity on all technical investigation and proposed technical solutions.
- Maintains knowledge of current good manufacturing practices (cGMPs).
- Primary degree in Science/Engineering discipline.
- You will have a minimum of 5 years' 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.
- Team player with an ability to work well across various departments on site as well as business partners.
- Excellent written, presentation, communication and investigation skills.
- Deadline focused individual.
Please call Conor Twomey today for further information on 087-0907204 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)