GDP Compliance Lead – Quality & Regulatory Affairs

Lever, Inc.; Dublin; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Group Private Medical Insurance

Group Life Assurance

Pension Scheme

Enhanced Maternity & Paternity Pay

Educational Assistance

Paid Volunteering Day

Job summary

WEP Clinical is seeking a Responsible Person (RP) to ensure compliance with EU Good Distribution Practice and national regulations. This role is crucial for maintaining a quality management system and safeguarding the supply chain.

The ideal candidate will possess a Bachelor’s degree in pharmaceutical sciences or related fields, alongside significant experience in GDP settings. Strong communication skills and attention to detail are essential, as is the ability to manage various stakeholders

Qualifications

• Bachelor's Degree or higher in relevant fields.
• Significant experience with GDP setting preferred.
• Completion of Responsible Person training program.
• Extensive knowledge of GxP requirements.
• Knowledge of Good Distribution Practice regulations.
• Effective verbal and written communication skills.
• Proactive and solutions-driven.

Responsibilities

• Implement and maintain a quality management system.
• Participate in Quality Management Review Meetings.
• Assess and approve GDP Change Controls.
• Ensure training programs are maintained.
• Coordinate recall operations for medicinal products.
• Approve subcontracted activities impacting GDP.
• Perform self-inspections at regular intervals.

Skills

Strategic

Collaborative

Proactive

Adaptable

Communications

Decision Making

Organisational Skills

Critical Thinking

Attention to Detail

Education

Bachelor's Degree in pharmaceutical, life sciences, or engineering

Tools

Microsoft Office Suite

Job description

WEP Clinical is seeking a Responsible Person (RP) to ensure compliance with EU Good Distribution Practice and national regulations. This role is crucial for maintaining a quality management system and safeguarding the supply chain.

The ideal candidate will possess a Bachelor’s degree in pharmaceutical sciences or related fields, alongside significant experience in GDP settings. Strong communication skills and attention to detail are essential, as is the ability to manage various stakeholders