To manage the New Jersey Training Program in accordance with both company and regulatory requirements. Includes Elizabeth, Edison, Morristown & non-R&D personnel in Owings Mills, MD sites
To manage the US training system (LMS) and ensure accurate training records, training curricula, personnel status changes, reporting and task qualifications.
Oversee the maintenance, validation and patch updates for the US Learning Management System (LMS)
To facilitate new employee cGMP Training, Annual cGMP Training, Contractor Training and SOP Training (when applicable) for all Actavis NJ sites
Manage the development and implementation of training department initiatives.
Assure all personnel have established training curriculums specific to their job function.
Assist area management to assure that all personnel are qualified to perform their assigned job functions.
To provide training notifications for new and revised SOPs per approved curricula for all NJ sites.
To manage the trainer qualification program (Train-The-Trainer) and Task Qualifications used to document On-The-Job-Training of personnel working in GMP areas.
To ensure training effectiveness is measured and to assess training needs to improve quality
To provide a blended learning approach for employees to remain familiar with their job function.
Assist area management to create, edit, and maintain Task Qualifications and Qualification Assessments.
To report training deficiencies to site management and present compliance metrics to the Quality Review Board
To track and report on-time, late and incomplete training for NJ sites.
Support FDA requests for Training Compliance of all NJ personnel
Maintain accurate Training Records and present training compliance reports and supporting documentation during FDA and third party inspections.
Perform investigations and write associated reports for deviations related to the NJ QA Training Group.
Manage the NJ QA Training Group (including performance reviews and resolving personnel issues).
4 + years experience Site Training function with a solid dose pharmaceutical manufacturer. Previous experience in a supervisory position.Specialized Knowledge and Skills
Must be able to perform management functions.
Current knowledge of cGMP's in the pharmaceutical industry.
Ability to interact with all levels of the organization and deliver training presentations commensurate to the respective trainee group. Ability to foster and work in a team environment.
Experience using Microsoft Office applications, including Word and Excel.
Must be well organized, detail-oriented, and experienced in working with minimal supervision.
Must possess excellent verbal and written communication skills.
Work Environment and Physical Demands
Prolonged sitting; bending; ability to operate a PC; ability to work in an office environment
A minimum of a Bachelor's degree is required*LI-LC1