Sr. mgr. global quality systems- specialized training statistical product analysis

1 month ago

Vadodara, India SUN PHARMA Full time

POSITION SUMMARY Direct the Global Quality Specialized Training program, ensuring a new portfolio of training offerings are offered to the Sun Global network, in order to enhance a baseline of Quality Compliance training.

(i.e. Investigator Qualifications, APQR/CPV, statistical product evaluation, 6 S inspection readiness, QP forums, etc.).

The incumbent will assure training compliance with all applicable regulatory requirements, Gx P’s, including Sun Pharma’s Global policies, standards, standard operating procedures, Learning Management Systems, Document Management Systems, etc.

Key responsibilities: Create specialized training and qualification programs, and then maintain those training offerings are periodically updated to 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/CAPA qualification training program for employees involved in quality and compliance activities.

Develop new Quality specialized training.

(Statistical product evaluation training programs, APQR/CPV, 6 S Inspection Readiness, Qualified professional (QP) / Batch certification continuous education forums, etc.) Training delivery, project management and Global roll-out schedule for all new Quality specialized training programs.

Liaison with both Human Resources and Quality Information Technology departments for implementation and institutionalization of Specialized Training programs.

Author, communicate and deliver to all levels of the organization from executive presentations to factory/lab areas, 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 (prioritized) Adult education learning models Training Development Training Delivery (class room & virtual) Technical report writing Project management Knowledge of Gx P’s, c GMP and other regulatory requirements.

ICH, and health authority regulations governing Quality investigations, CAPA, APQR & CPV Time management Site service orientation

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