To ensure Teva Pharmaceutical Ireland’s Inhalation & Research and Development Business Units operate in accordance with Regulatory, Corporate and Company requirements.
Specific Key Result Areas:
To ensure that all work carried out is in compliance with the required standards conforming to company, cGMP, cGLP’s, SOP’s, regulatory regulations and guidelines, H&S and environmental guidelines;
To provide support for manufacturing investigations and approval as required;
Review and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirements;
To conduct simulated inspections across the site;
To support Regulatory and Customer Audits, maintain risk registers;
Participate in knowledge management and ensure information is shared throughout the company;
To provide support for site Supplier Quality and on-going supplier management;
People Management: Ensure direct reports are given the coaching and support required to perform their duties to agreed standards;
To deliver Customer Service (both internal and external) through agreed timelines due in accordance with quality standards and cost control;
Quality Systems Development: To develop and improve quality systems by identifying areas for improvement (NVAA’s and key variances) and take corrective action as required ensuring continuous improvement in accordance with Company Continuous Improvement Process.
Degree Qualification in a Science Discipline and work experience in the Pharmaceutical Industry.
Knowledge, Skills and Experience
Experience in a Compliance Role with Inhalations experience would be an advantage;
In depth knowledge and understanding of interpretation of cGMPs and regulatory requirements, experience of regulatory inspections and customer audits;
Auditing skills and/or lead auditor trained;
People Management experience would be an advantage;
Technical report writing skills;
Excellent computer skills;
Excellent planning and organisational skills to ensure workload prioritisation and schedule adherence.