GM Global Quality

4 weeks ago


Vadodara, India SUN PHARMA Full time

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 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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