Sr. Specialist – Quality Training
Responsibilities include designing , implementing and monitoring training program, ensuring cGMP Training, qualification , on the job training and visual inspection training program
B. Pharm, M. Pharm, MSc. with 5+ years of experience in quality assurance or manufacturing function of sterile dosage forms.
Understanding of pharmaceutical manufacturing, packaging and quality systems
Creates or leverages existing communication materials and information to aid Work Team in delivering goals/objectives
Contributes to the development of, and often delivers, presentations within the Department
Solicits input and explains difficult concepts and persuades others to adopt a point of view.
Effectively shares own point of view and rationale.
Responsible to design, implement and monitor training quality systems.
Ensures new hires orientation trainings conducted in timeframe and new hires moved to their respective work areas within the stipulated time as per business requirements.
Identify training gaps and address with appropriate departments.
Deliver Interactive class room training for cGMPs, on annual basis for all the employees.
Design, implement and monitor employee qualification program. (Train the trainer)
Represent site as training SME for regulatory audits.
Responsible in Coordinating the internal/ external training programs.
Responsible for approval of training quality systems SOPs.
Responsible for ensuring training related CAPA implementation and closer.
Responsible in monitoring overdue trainings and coordinating with department HODs.
Monitor training metrics parameters on weekly and monthly basis.
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