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Quality and Compliance Manager

Job description

About Your New Employer

The client is one of the leading multinational pharmaceutical companies and is now recruiting a Quality and Compliance Manager to join a high-performing Quality team in Cork. In this management role, you will be responsible for the quality assurance compliance activities in the Cork Site. You will also lead the implementation and maintenance of quality assurance activities in compliance with the current GMP regulations. You will have a chance to work every day to discover and address many of the world's most pressing health challenges. When you have patients depending on your solutions, you look for the best people to be part of the team.

 

About Your New Job

  • 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.

 

What Skills You Need

  • Degree in Science or related discipline 
  • Education to meet the requirements for the position of Qualified Person as defined in Article 49 Directive 2001/82/EC.
  • Minimum 5 years of experience in Pharmaceutical Environment
  • Experience to requirements for the position of Qualified Person as defined in EU GMP volume 4 and annex 16.
  • Experience of GMP Auditing and Documentation

 

What’s on Offer

Permanent role, with an attractive salary of €75-85,000 along with benefits and a performance bonus.

 

What’s Next​

  • Apply now by clicking the “Apply Now" button or call me, Barbara Szatkowska on +353 86 796 1534 or if the job isn’t quite right but you are looking for something similar, please get in touch!

 

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