Recruiters Comments: Our client, a pharmaceutical multinational is currently looking for a Technical Writer/Compliance Specialist to join their team in Limerick. This is initially a 12-month contract with a strong possibility of extension.
Job Description:
- Manage Deviations, CAPA, Change Control, Audits, and Quality risk management.
- 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.
- Responsibility for ensuring compliance with all aspects of Quality
- Responsible for generating and maintaining Life cycle document across automation platforms.
- 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.
- Liaise with QA to provide accurate and efficient communication ensuring clarity on all technical investigation and proposed technical solutions.
- Coordinate Compliance activities with and seek team support from QA, Validation Engineering and Manufacturing.
- Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
- Ensure consistency by provide guidance and direction in the preparation of all Compliance/Validation documents.
- 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.
- Excellent written, presentation, communication and investigation skills.
- 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.
- Direct experience and in-depth knowledge of automation platform desirable.
- Deadline focused individual.
