Training Manager

SUMMARY:

Prepare and provide training for all facility personnel with a specific focus on the cGMP areas including manufacturing, quality and engineering.    Develops and executes the master training program for the site  to maintain cGMP compliance ensuring employees have the proper training to perform their job assignments within cGMP requirements.

DUTIES AND RESPONSIBILITIES:

The primary duties and responsibilities of this position include the following.

• Administer all aspects of the Operator Instruction Manual (OIM) program to ensure that Operators are properly qualified.
• Conduct training on all new batch records and for all batch record revisions.
• Ensure that all Manufacturing SOP manuals are current and prepare and conduct training on all new SOPs and SOP revisions.
• Prepare and conduct annual GMP training for the facility.
• Conduct new employee orientation for all departments.
• Conduct ERP system training for all departments.
• Coordination of all third party training either on-site, or off-site.
• Coordinate training activities outside of Manufacturing and conduct training, as requested.
• Administer all plant-wide training documentation systems.
• Work with other manufacturing sites within the MFG network in North America to insure consistent training methods are being used
• Assist other manufacturing sites with the development of training programs and tools to insure cGMP compliance across all manufacturing sites
• Develop and/or implement new software related to training and electronic batch records
• Assist the HR department with the implementation of the selected Learning Management Software
• Manage any departmental employees or employees assigned to assist with the training department
•  Perform Manufacturing support as necessary and requested.
•  Prepare, submit and review SOP and batch record revisions for Manufacturing, as necessary.
•  Perform other administrative tasks for Manufacturing, as requested by Manufacturing management.
  • Eight or more years of experience in a regulated manufacturing environment, preferably in the Pharmaceutical industry
  • A thorough knowledge of Good Manufacturing Practices
  • Experience in both quality and manufacturing in order to maintain build appropriate training system
  • A high degree of oral and written communication skills

EDUCATION AND/OR EXPERIENCE:

• Eightor more years of experience in a regulated manufacturing environment, preferably in the Pharmaceutical industry
• A thorough knowledge of Good Manufacturing Practices
• Experience in both quality and manufacturing in order to maintain build appropriate training system
• A high degree of oral and written communication skills

Location: Ohio (Local Candidates only – No relocation provided)