· Coordination with Project Management, Clinical Operations, Data Management, and HR Departments for quality-related activities. Liaising with respective functional heads for SOP implementation, document control, and training compliance.

· Coordination with internal audit teams for planning and execution of internal quality audits.

· Coordination with sponsors, vendors and External Auditors during audits or inspections.

· Interaction with site personnel. CRO partners, and regulatory authorities as required for AQ activities.

· Communication with training consultants and external service providers for quality system support.

· Support training and awareness programs related to GCP, GLP and other quality systems.

· Conduct and support internal, vendor, and site audits as per the annual audit plan.

· Track, review and close CAPA (Corrective and Preventive Actions) and deviations within defined timelines.

· Assist in the preparation and review of QA- related reports,



logs and metrics.

· Participate in continuous improvement initiatives and ensure adherence to company policies and regulatory standards.

· Manage SOP control, issuance, revision, and archival processes.

· Review and ensure compliance of trial master files (TMF), study documents and quality records.

· Strong knowledge of SOP writing and document Control practices.

· Excellent attention to detail and analytical skills.

· Valuable communication and interpersonal coordination skills.

· Proficient in MS Office and electronic quality systems.

· Ability to handle audits, identify gaps and implement corrective actions effectively

· Team player with a commitment to continuous improvement and regulatory compliance.

Pay: ₹450,000.00 - ₹600,000.00 per year

Work Location: In person

📌 Senior Executive - Quality Assurance (Gurugram)
🏢 Alzasyno Life Sciences
📍 Gurugram