Qualified Person

Qualified Person Required by a Well Established, Leading Pharmaceutical Wholesaler of Pharmaceutical and Medical Products 

Permanent Role with Predominantly Remote Working and Some Routine On-Site Duties at Scottish Facility, Reporting to Quality and Regulatory Manager

ROLE (Includes)

Accountable for Conformance to Regulatory Requirements as per Directives 2001/20/EC and Article 51 of Directive 2001/83/EC

• Responsibility for Batch Release as per EU/UK Guidelines by Ensuring the Batch Manufacture Complies with the Provisions of the Marketing Authorisation, Including Requirements for Importation if Relevant
• Manufacture has been Carried Out in Accordance with GMP (Imported Batches Manufactured to Standards Equivalent to EC GMP)
• Principal Manufacturing and Testing Processes are Validated
• Deviations or Planned Changes are Approved
• Changes Requiring Variation to the Marketing Authorisation are Notified and Authorised by Relevant Authority
• All Necessary Production and Quality Control Documentation Completed and Endorsed by Appropriate Staff
• All Audits Conducted as Required by the QA System

Routine Quality Audits of the Facility to Ensure Compliance with current EU/UK GMP

Establish and Maintain the Internal Audit Schedule and Ensure its Completion

External Audits and Compile External Audit Reports

Management and Assistance with the Site Change Control

Technical Support for New Product Introductions and Existing Products, Ensuring Compliance with the Registered Dossier

Updating of Existing Quality Manual Procedures to Ensure Compliance with EU/UK GMP

Third Party Management Activities, Including Audit of Suppliers and Contract Resources

Review and Approve Process and Cleaning Validation Protocols

REQUIRED

• Appropriate Science Based Degree Qualifications
• Accredited Qualified Person in Accordance with Directives 2001/20/EC and Article 51 of Directive 2001/83/EC
• Minimum 3 Years' Experience in a Similar Role
• Experience of Implementing and Managing a Quality Management System
• Proven Project Management Experience
• Experience of Leading Continuous Improvement Initiatives
• Direct Line Management Experience

REMUNERATION

• £100K Subject to Qualifications and Experience

RESPOND

• Call Terry Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail terry@arxconsultancy.com with Your Application, Including Your Current CV