Specialist Recruiter at ApicalGo Consultancy
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Manager - Quality Assurance & Clinical Research (8-12 yrs)
The Manager - Quality Assurance will perform the following activities :
- Responsible for all activities involving quality assurance and compliance to applicable regulatory requirement.
- Coordination, development and maintenance of the organization's SOPs
- Reviews the organization's SOP(s) and also to track & instigates annual review and revision of SOP(s)
- Ensure distribution and communicates all SOP releases and related trainings.
- Trains and ensure that employee had received trainings on organization's implemented procedures and applicable regulatory laws/guidelines e.g. Schedule Y, ICH-GCP and other industry requirements.
- Plans audit activities and processes including assessment and allocation of sufficient resources.
- Planning, scheduling, conducting, reporting, and evaluation of internal departmental audits (System Audits) to ensure compliance
with applicable regulations and SOP(s)
- Planning, scheduling, conducting and reporting Project Audits and Investigator Site Audits to ensure compliance with protocol and applicable regulations
- Participate in due diligence and qualification efforts in the selection of vendors to provide Services through performing vendor audits.
- Reviews of Audits Report generated by the reportees
- Advice/Assist in corrective actions identification and preventive action.
- Coordinate action plan implementation and quality control from the observations made during the Quality Assessment visits.
- Assigned audits activities to reportees and provides guidance/supervision
- Ensure compliance prior to the evaluation of the organization by external clients/regulators to ensure expectations for quality
- Ensures appropriate development and training of audit staff for proficiency with applicable standards.
- Participate in risk assessment and risk mitigation from a quality perspective.
- Notify Senior Management of any potential quality issues.
- To conduct Quality Council Meetings every month.
- To deal with all levels within the organization as well as with external parties, including regulatory authorities.
- Promotes continuous improvements in quality systems and department infrastructure
- Participates and represent QA in meetings and discussions as needed
Experience : 8 years, Min 4 years from CRO
Education : Masters in Life sciences
Location : Delhi NCR