Teva Senior Compliance Officer 

Ireland 

261303712

We would like to invite applications for the role of Senior Compliance Officer at our site in Waterford.

The Senior Compliance Officer effectively manages the compliance systems and provides compliance support and advice as required. They will ensure that the company is ready for audits and cross compliance checks and work with a variety of departments internal and external to ensure compliance and audit readiness.

• Take ownership of SOP’s within the department to ensure compliance at company, group and regulatory level.
• To conduct/participate in simulated pre-approval and post-approval regulatory inspections in accordance with FDA and EU regulations to ensure the company is at all times ready for audit and in compliance.
• To ensure that direct reports (3) are given the coaching and support required to perform their duties to agreed standards of performance in line with Company Performance Management System.
• To supervise/manage the Quality Compliance Officers, Complaint Investigators and Documentation Administrators where applicable.
• To ensure the TPI audit programme is executed and effectively managed.
• To maintain and improve the relevant Company Quality Systems in accordance with Regulatory and Business requirements.
• To ensure that Global Corporate Standards and Regulatory updates are implemented according to assigned timelines.
• To ensure the Quality Technical Agreements are implemented and updated accordingly.
• To coordinate preparation of Quality Council Meetings
• To oversee and manage all supplier investigations and changes.
• To identify areas for improvement (NVA’s and key variances) and take corrective action as required, to ensure continuous improvement in accordance with company Continuous Improvement Process.
• To deliver Customer Service (both internal and external) through agreed timelines due in accordance with quality standards and cost control.
• To agree and monitor departmental budget/capital expenditure in order to meet budgeted targets within the Department function.
  

Are you?

• Educated to Degree Level in Pharmaceutical/ Life Sciences with strong Industry experience in a pharmaceutical Validation, Regulatory or QA/Compliance environment
• People management experience in an EU/FDA approved facility desirable.
• Experience of Regulatory inspections and customer audits is essential

Do you have….

• Knowledge of Regulations and sources of regulatory information.
• Knowledge of relevant cGMP and Regulatory Body requirements.
• Knowledge of Employee legislation, H&S and Environmental legislation.
• Strong Understanding of production and laboratory systems to effect judgement decisions consistent with quality and business needs.
• Good knowledge of report writing, Project Management, Continuous Improvement and problem solving tools.
• SAP knowledge.
• Knowledge of Trackwise would be desirable.
  

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