Quality Assurance Specialist Training

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

Driven to uphold the highest standards in pharmaceuticals? Step into this role where your expertise ensures operational integrity and supports the delivery of safe, effective treatments worldwide.

R&D Partners is seeking a dedicated professional to lead the training and employee qualification system at a pharmaceutical manufacturing site. This role ensures that all employees and contractors are effectively trained and qualified for their roles, adhering to Good Manufacturing Practices (GMP) and regulatory standards. You will oversee the entire training process, from identifying training needs to evaluating effectiveness, while maintaining compliance with EU and US regulations.

Please note that to be considered for this role you must have the right to work in this location.

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.

Key Skills and Requirements:

• Background in pharmacy, chemistry, biotechnology, quality, engineering, or related fields.
• Experience in training, quality assurance, or operational qualification within a regulated environment.
• Knowledge of EU GMP, US FDA cGMP, and data integrity requirements.
• Hands‑on experience with electronic learning management systems (LMS).
• Ability to design and evaluate both classroom and on‑job training programs.
• Strong organizational and communication skills.
• Certification in training, instructional design, or coaching is a plus.
• Eligibility to work in Ireland.
• €42,000 to €47,000 per annum.

For more information, please contact Billy O'Brien.