Zydus Cadila
Location
Work from home | India
Job description
To follow the cGMP with the available infrastructure.
To do the work as per cGMP and GDP.
Review of documentation.
To ensure proper complete documentation in thedepartment.
Preparation of Standard Operating Procedure, Documents,Validation Protocol and review and approve.
Implementation of corrective actions and preventive actions.
Ensure adherence to relevant SOPs for specific job.
To investigation of Market complaint, product failure,system deviations.
To coordinate with all departments i.e. with Q.C., Production,Warehouse, Engineering, IT, HR-Admin. for training related activities,planning, data maintenance and ensure compliance pertaining to training.
Handling of Market complaint and CAPA.
To inform department Head/plant head for any abnormalitiesi.e. deviations/events/safety events and for other day-to-day activities and toparticipate in investigation activities.
Responsible for QMS handling Initiation/Closure and closurerelated to Production (CAPA, Track Wise)
Preparation of Risk assessment /Protocol.
Overall responsibility of Training related activities atsite.
To ensure completion of activities as per requirement withinstipulated timeline.
To ensure compliances to all regulatory, internal audits.
2.Requirements
Qualification: B. Pharm/M. Pharm
Years of Experience : 05 - 10 years
Experience / Exposure in :
Must have knowledge and experience inregulatory audit
Should have faced regulatory audits likeUSFDA, MHRA, MCC and ANVISA etc.
From which departments, people can apply:
Quality Assurance
Job tags
Salary
