Lead Quality Systems Manager

3 weeks ago


Vadodara, Gujarat, India SUN PHARMA Full time

POSITION SUMMARY

Oversee the Global Quality Specialized Training program, ensuring a new portfolio of training offerings are provided to the Sun Pharma network to enhance the baseline of Quality Compliance training. This includes Investigator Qualifications, APQR/CPV, statistical product evaluation, 6S inspection readiness, QP forums, and other Quality compliance education.

The incumbent will ensure training compliance with all applicable regulatory requirements, GxP's, including Sun Pharma's Global policies, standards, standard operating procedures, Learning Management Systems, Document Management Systems, and other related systems.

Key Responsibilities:

  • Create specialized training and qualification programs, and periodically update those training offerings to align with industry standards and 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, such as statistical product evaluation training programs, APQR/CPV, 6S Inspection Readiness, Qualified professional (QP) / Batch certification continuous education forums, and other related topics.

Training delivery, project management, and Global roll-out schedule for all new Quality specialized training programs.

Liaison with 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 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 (classroom & virtual)

Technical report writing

Project management

Knowledge of GxP's, cGMP, and other regulatory requirements

ICH and health authority regulations governing Quality investigations, CAPA, APQR & CPV

Time management

Site service orientation



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