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

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