GM Global Quality
4 weeks ago
POSITION SUMMARY
Direct the Global Quality Specialized Training program, ensuring a portfolio of training offerings. (i.e. investigations, CAPA, APQR/CPV, statistical product evaluation, inspection readiness, 6S, etc.).
The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’ s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures.
Key responsibilities:
Ensure training materials are up-to-date, align with industry standards, and comply with regulatory requirements. Collaborate with cross-functional teams to identify and address training needs based on site audits, investigations and quality incidents within the Sun Pharma network. Develop, implement and monitor a comprehensive investigation qualification training program for employees involved in quality and compliance activities. Develop and implement Quality Specialized Training (statistical product evaluation training programs, APQR/CPV, Inspection Readiness, 6S, Train the Trainer, etc.) Liaison with Human Resources and Informational Technology departments for implementation of specialized training programs Project Management of all new Quality Specialized Training programs Author, communicate and present executive presentations on all Specialized Training and qualification programsMINIMUM EDUCATION/EXPERIENCE REQUIREMENTS
Health Science, Pharmacy or Industrial Engineer Graduate or Equivalent
15 years Pharmacy industry experience
REQUIRED SUCCESS ATTRIBUTE
Knowledge of GxP’s, cGMP and other regulatory requirements. ICH, and health authority regulations governing Quality investigations, CAPA, APQR & CPV Technical report writing Adult education learning models Project management Time management Customer/Site service orientationSecondary Success Attributes
Information Technology Learning Management Systems (LMS) People Connect Attention to detail Business traveler Effective Communication from operator to executive levels-
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