Technical Writer/Compliance Specialist

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).

Role:

Education and Experience:

• 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.

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