Job Description

Manage the sites training program covering cGMP requirements, and corporate policy, and other topics to a broad spectrum of professional individuals that serve companys manufacturing plant, research and development laboratories, and general business operations. Reporting to the Compliance Head, and using independent judgment, apply ISO, cGMP, and FDA procedures and regulations to activities involving quality assurance and compliance for pharmaceuticals and medical devices. How you ll spend your day Evaluate training needs and participate in the delivery of training materials for the company including Manufacturing, Quality, and Support groups ensuring compliance with the training policy and all training procedures. Administer the LMS and coordinate training activities, including scheduling sessions, updating training records, generating reports, etc Maintain a compliant training record keeping (data entry and hard-copy files) system. Assist in developing curricula of on-the-job training requirements including appropriate documentation, qualifying trainers, and assuring approved training content and working with area supervision, manages assignments within the Learning Management System (LMS) Prepare training completion metrics for dissemination at Quality Review Board meetings. Work with area managers to determine training frequency/re-training intervals based on roles and responsibilities. Assist in developing training assessment tools, such as tests and competency evaluation worksheets. Review Quality records to ensure conformance to approved procedures and cGMP. Maintain an annual scheduled training calendar, ensuring on-time delivery of annual GMP training and other GxP trainings. Act as Single Point of Contact (SPOC) between Corporate Documentation & Training group and site, working towards harmonization of the site training and site procedures with Corporate expectations. Creates and manages documentation requests in electronic systems such as EDMS, Master Control, and Trackwise. in a timely manner to meet established deadlines Assists in monitoring documentation due for annual periodic review. Your experience and qualifications Qualification : Bpharm /Mpharm/Bsc/Msc with relevant experience in Pharmaceutical Industry. Experience: 8+ years of related experience in a pharmaceutical/ drug or medical device industry, or other FDA regulated industry. Ability to present self in a professional, credible manner and communicate effectively at all levels of the organization. Ability to prioritize and organize own work, multi-task, meet deadlines and keep commitments. Excellent administrative & organization skills. Positive attitude: values others and works well independently and in a team environment. Excellent verbal, written and interpersonal communication skills

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