GMP Training Lead – QA & Compliance Expert

R&D Partners; Tipperary; On-site; EUR 42,000 - 47,000; Full time

Job summary

R&D Partners is seeking a dedicated professional to lead the site's training and employee qualification system at a pharmaceutical manufacturing site. You will oversee the training program, ensuring EU GMP and US FDA cGMP compliance, while maintaining high standards of quality and regulatory adherence.

The role requires expertise in training, quality assurance, and operational qualification within a regulated environment, with hands-on LMS management and strong collaboration across departments.

Qualifications

• Experience in training, quality assurance, or operational qualification within a regulated environment.
• Knowledge of EU GMP and US FDA cGMP.
• Eligibility to work in Ireland.

Responsibilities

• Develop and manage the site's training strategy, policies, and annual plans.
• Ensure training programs meet EU GMP, US FDA cGMP, and internal quality standards.
• Act as the subject-matter expert during audits and inspections.
• Identify training needs based on job tasks, risks, and performance data.
• Design engaging learning materials, including e-learning, workshops, and practical assessments.
• Oversee on-the-job training programs, ensuring trainers and assessors are qualified.
• Manage the electronic training system, ensuring accurate records and compliance.
• Deliver or coordinate key training sessions, such as GMP induction and refresher courses.
• Evaluate training effectiveness and implement improvements based on feedback and outcomes.
• Collaborate with various departments to align training with operational goals.

Skills

Training management

GMP knowledge

Quality assurance

LMS experience

Communication skills

Education

Science degree

Tools

LMS software

Audit tools

Job description

R&D Partners is seeking a dedicated professional to lead the site's training and employee qualification system at a pharmaceutical manufacturing site. You will oversee the training program, ensuring EU GMP and US FDA cGMP compliance, while maintaining high standards of quality and regulatory adherence.

The role requires expertise in training, quality assurance, and operational qualification within a regulated environment, with hands-on LMS management and strong collaboration across departments.