Gm Global Quality
2 days ago
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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 programs
**MINIMUM 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 orientation
**Secondary 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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