Training Program Lead – Cgmp

Training Program Lead – Cgmp

Requirements

• Bachelor’s Degree Life Sciences, HR, Business or Education with 5+ years of relevant experience with managing a site training program for a medium to large pharmaceutical manufacturing organization preferred.
• Master’s degree preferred.
• Experience with the design and delivery of cGMP and employee development training programs.
• Solid background in curricula development and experience in the use of computer systems and applications (Learning Management Systems, Document Management Systems and Microsoft Office).
• Excellent writing, public speaking, and organizational skills.
• Familiarity with Training Within Industry (TWI) methodology of on-the-job training is helpful.

Responsibilities

• Maintain the Learning Management System (LMS), MyUniversity, for DPT Laboratories, Ltd.
• Primary contact at the site for interfacing with the Global Learning support teams to ensure the site is aligned with Global policies and procedures.
• Facilitate and develop the site training programs in accordance with approved policies, regulatory guidelines, and standard operating procedures to satisfy employee and departmental training objectives.
• Act as the primary administrator of the LMS.
• Act as a subject matter expert for the LMS as well as provide requested training documentation during internal, regulatory and client inspections.
• Facilitate classroom or electronic training for the site training for all applicable departments to include: Annual GMP training, data integrity, On the job Train-the-Trainer Qualification, Quality Culture, Human Error Prevention (HEP), and other Compliance related training initiatives.
• Qualify on-the-job trainers using approved methods and assist in the development of technical training materials.
• Facilitate and assist site departments in developing, maintaining, and implementing training curricula.
• Provide reports and relevant metrics to site leadership, as requested, to monitor training compliance and quality objectives.
• Ensure that documentation of training events is complete, accurate and entered into the LMS.
• Know and comply with all applicable Standard Operating Procedures (SOPs) and Work Instructions (WI). Assist in reviewing, recommending, and revising SOP(s) as required. Assist with procedure training and document appropriately.
• Support scheduling, auditing, reporting, and monitoring self-inspection, observations, CAPAs, and effectiveness checks.
• Support the supplier audit program according to site procedures and regulatory expectations.
• Support the equipment calibration service provider qualification and audit program according to site procedure and regulatory expectations.
• Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.
• Perform other duties as assigned.

Preferred Qualifications

• Master’s degree preferred.
• Familiarity with Training Within Industry (TWI) methodology of on-the-job training is helpful.