This is a great opportunity for a Training Manager with experience in GCP and GMP training to grow with a company that values its employees and its customers/patients. This is a company that is determined to make the best medicines possible for unmet patient needs and believe that the people that work with them are what make the difference. They hire the highest caliber people and expect each individual to make a significant contribution. They also place a high value on both people and ideas and therefore expect extraordinary achievements.
The candidate selected for this position will be responsible for the overall training program which entails, creation and updating of classes for Clinical Research, Manufacturing and Lab professionals in a GCP, GMP and FDA regulated environment.
Responsibilities: - Create, organize and manage periodic site training programs to ensure compliance with GMP and GCP standards - Evaluate the current GMP/GCP training program ensuring that the program is complete and effective. - Will revise the program as needed. - Work with heads of each department to establish specific training needs - Ensure that GMP and GCP training records are maintained and reviewed -Maintain SOPs and manage the review, change and implementation process for SOPs - Audit clinical sites and recommend changes and training to ensure that they are following current SOPs and GCPs
Requirements: - BSc ' Scientific related field - Minimum of five years of pharmaceutical clinical research industry experience - Previous experience in training both GMP and GCP. (Someone that has previously been in a GXP Training position covering both GMP and GCP would be preferred. - Minimum of three years of training experience in a pharmaceutical / clinical research environment - Must be able to communicate effectively in writing and verbally with other employees on all levels and regulatory agencies. - In depth knowledge of US FDA, EU and JP GMP/GCP regulations - Must be able to handle a heavy workload, stressful situations and multiple deadlines. - Travel 20 ' 40%
Benefits: - Medical/Dental/Vision plan - Paid time off - Holidays - 401k with a company match - Tuition reimbursement
If you are interested in additional information, please send your resume and cover letter to:
Kris Saprano [Click Here to Email Your Resumé] www.linkedin.com/in/krissaprano Office: (303) 427-4140
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