JOB ID:164268
Job Type
Full Time
Functional Area
QA/Testing
Industry
Pharma/Biotech/Clinical Research
Education
Not Specified
Experience Required
15 - 18 Yrs
Key Skills Required
governing quality investigations, capa, apqr & cpv • technical report writingOther Skills Required
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:
1. 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.
2. Collaborate with cross-functional teams to identify and address training needs based on site audits, investigations and quality incidents within the Sun Pharma network.
3. Develop, implement and monitor a comprehensive investigation/CAPA qualification t
... See MorePOSITION 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:
1. 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.
2. Collaborate with cross-functional teams to identify and address training needs based on site audits, investigations and quality incidents within the Sun Pharma network.
3. Develop, implement and monitor a comprehensive investigation/CAPA qualification training program for employees involved in quality and compliance activities.
4. Develop new Quality specialized training. (Statistical product evaluation training programs, APQR/CPV, 6S Inspection Readiness, Qualified professional (QP) / Batch certification continuous education forums, etc.)
5. Training delivery, project management and Global roll-out schedule for all new Quality specialized training programs.
6. Liaison with both Human Resources and Quality Informational Technology departments for implementation and institutionalization of Specialized Training programs.
7. 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 See Less
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 5.1 billion. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.