- 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.
- 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, 6S Inspection Readiness, Qualified professional (QP) / Batch certification continuous education forums, etc.)
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Dir. Global Quality – Specialized Training - Vadodara, India - SUN PHARMA
Description
Job Description
POSITION SUMMARY
Direct the Global Quality Specialized Training program, ensuring a new portfolio of training offerings are offered to the Sun Global network. (i.e. Investigator Qualifications, APQR/CPV, statistical product evaluation, 6S inspection readiness, QP forums, etc.).
The incumbent will assure individual compliance with all applicable regulatory requirements, GxP's, including Sun Pharma's Global policies, standards, standard operating procedures, Learning Management Systems, Document Management Systems, etc.
Key responsibilities:
Collaborate with cross-functional teams to identify and address training needs based on site audits, investigations and quality incidents within the Sun Pharma network.
Training delivery, project management and Global roll-out schedule for all new Quality specialized training programs.
Liaison with both Human Resources and Quality Informational Technology departments for implementation and institutionalization of Specialized Training programs.
Author, communicate and deliver 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
Training Development
Training Delivery (class room & virtual)
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
Roles
Additional responsibilities can be assigned as required.
WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS
Incumbent performs work assignments in both normal office and non-aseptic manufacturing/packaging environments. Moderate to loud noise level is common in production rooms. The incumbent must be able to comply with the gowning requirements for entry into controlled non-aseptic manufacturing areas, and wear personal protective equipment as required.
DELEGATION OF RESPONSIBILITY
In the absence of job holder, delegation of responsibility will be as follows:
Upward Delegation – Strategic corporate responsibilities to higher level
Downward Delegation – Site Operational responsibilities to indirect project reports or similar peer job roles