About Clinical Research Network India:
Clinical Research Network India Pvt. Ltd. is a Contract Research Organization that was established in 2015 with a formidable team and experiences in Clinical Trials Phase I to Phase IV and Pharmacovigilance services.

Clinical Research Network India continuously aims to design and provide quality and cost-efficient processes to make India a global leader in ethical clinical research. CRN India provides comprehensive solutions in Clinical Project Management, Medical Writing, Regulatory Affairs, Data Management, and other core clinical trials solutions along with clinical safety and pharmacovigilance.

Job Title: Director
- Quality Assurance (QA):
Organization: Clinical Research Network India Pvt. Ltd.

Industry: Clinical Research / CRO

Department: Quality Assurance

Location: Noida, Sector 142

Employment Type: Full time

Position Overview:
The Director - Quality Assurance (QA) will lead and oversee the organization’s Quality Management System (QMS) for all clinical research operations within the CRO.



The role is responsible for ensuring compliance with applicable global and local regulatory requirements, including ICH-GCP, CDSCO, US FDA, EMA, MHRA, and other international standards relevant to clinical trials, pharmacovigilance, bioavailability/ bioequivalence studies, and related clinical research activities.

Key Responsibilities:
Technical Expertise:
- Review and Approval of Protocols, Reports and associated Deviations as applicable.
- Maintain SMF (Site Master File), Validation Master Plans & Inventory of systems.
- Conducts training as required.
- Generation of SOPs/ other documentation as applicable.
- Maintain change control system.
- Handling of quality elements (Change control, deviation CAPA, QRM, SOP, Quality metrics).

Quality Management & Regulatory Compliance:
- Lead the development, implementation, and maintenance of the organization’s Quality Management System (QMS).
- Ensure compliance with applicable regulati

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