GM Global Quality
2 weeks ago
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:
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, 6S 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 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 orientationSecondary Success Attributes
Information Technology Learning Management Systems (LMS) People Connect Attention to detail Business traveler Effective Communication from operator to executive levelsRoles
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
___________________ __________
Department Head Date
____________________ __________
Human Resources Date
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
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