QA Specialist (Training Specialist) to lead and manage the site training programs / activities related to GMP operations. Develop and implement GMP Training requirements / Training schedule to ensure compliance with regulatory requirements, company policy and procedures. Manage and develop training metrics for site and identify scope of improvements.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Lead and manage of site training activities and ensure training criteria is defined and adhered to a high standard as per site procedures and compliant with any requirements of EU Rules governing medicinal products Volume 4 and the US FDA Code of Federal Regulations.
• Ensure that Training Procedures and systems are continually evaluated and updated to reflect regulatory changes, thereby maintaining compliance with regulatory requirements.
• Review processes, identify skills gaps, training, and development needs of the business.
• Develop, deliver, and evaluate the effectiveness of training programs, policies and procedures (SOP).
• Lead the continuous improvement of training and development programs and systems by keeping up to date with best practices and new trends/ developments and by acquiring/ maintaining familiarity with critical process and product applications to ensure training material and content is appropriate.
• Deliver GMP training (annual, refresher etc.), Regulatory training and any other training related to the Quality Department and other Departments, as required.
• Manage the compliance of Training Management Software i.e. metrics reporting, audit trail review, annual system review
• Ensure Site training policy is current and in line with corporate and regulatory requirements.
• Ensure Training CAPA effectiveness criteria is met, and monitoring of Unplanned events related to Training.
• Support training activities for cross-functions - preparation / execution of on-the-job training.
• Participate in and provide support for Training Activities for regulatory, customer and/ or corporate audits.
• Ensure all training is delivered as per schedule and to budget.
Education & Experience:
• Science Graduate with minimum 3-year experience in a QA Specialist (Training) role in the Pharmaceutical Industry
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