If you are passionate about Quality and are an experienced Leader, we have the perfect role for you! We are recruiting for a QA Compliance Manager to join our clients high performing Quality team in Cork. In this management role, you will be responsible for the quality assurance compliance activities and will also lead the implementation and maintenance of quality assurance activities in compliance with the current GMP regulations.

 
Why you should apply:
 

• You’re passionate about your profession and strive for excellence in everything you do.
• You’re ambitious and thrive in working environments where high standards and patient safety are key.
• You bring new ideas to the table, are well versed in industry best practice and innovative talent solutions, and you will be integral to the continuous growth of the organization.

 
What you will be doing:
 

• Managing all QA Compliance Activities including the Site Document Controller / QA Administrator, and QA Compliance Specialists, project related resources as required.
• Completing the Annual Appraisals of the QA staff.
• Partaking of department budget management
• Management of the electronic documentation system.
• Ensure appropriate QA Reviews / Approvals of GMP documentation eg, SOPs, reports, methods, specifications, validation protocols etc.
• Management of the Archive System of QA documentation.
• Preparation of the Site for Regulatory Inspections and Internal Compliance QA Audits and management of same.
• Preparing and reviewing QA department reports and metrics
• Site Business Administrator for SolTRAQS – Exception Reports, CAPA, Change Requests, Planned Deviations, AudiQ and Customer Complaints.
• Establish the requirements for conducting and documenting Site Management Reviews so as to ensure the suitability and effectiveness of the quality system.
• Management and delivery of all QA Activities related to New Product Introduction. This includes ensuring QA Compliance in all phases of the NPI Projects – Feasibility, Demonstration and Validation and QP release as required.

• You will have a 3rd Level Qualification in Science, Quality or Engineering to Degree Level
• Minimum 5 years in Pharmaceutical Environment, with 3 years proven people management experience
• Education to meet the requirements for position of Qualified Person as defined in Article 49 Directive 2001/82/EC Desirable but not essential
• High level of attention to detail and mental concentration to ensure accuracy and total compliance with procedures.
• Results-driven striving to meet all targets and metric standards