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Role Objective / Major Purpose of the Job
To support Quality Assurance activities within CSBU R&D; by ensuring compliance with applicable GMP, quality systems, regulatory requirements, and internal procedures. The role involves review and monitoring of R&D; documentation, quality events, investigations, CAPA, change controls, and other quality-related activities. .

Principal Tasks & Responsibilities

Review and ensure compliance of R&D; documentation, protocols, reports, SOPs and quality records with GMP and internal quality requirements.

Manage quality events including deviations, investigations, CAPA and change controls, ensuring timely review and closure.

Support audits and inspections by preparing required documents, coordinating responses and tracking closure of observations.

Monitor R&D; quality systems and identify compliance gaps, recurring issues and opportunities for process improvement.





Conduct and support quality training for R&D; personnel and promote a solid culture of GMP, documentation and quality compliance.

Key Skills & Competencies

Functional / Technical
Robust knowledge of GMP, QMS, SOPs, Deviation, CAPA and Change Control.
Good understanding of pharmaceutical R&D; processes, documentation and audit/inspection requirements.
Proficiency in quality documentation, data review, investigation and compliance monitoring.

Behavioural
Attention to detail with solid analytical and problem-solving skills.
Effective communication and stakeholder coordination across R&D; and support functions.
Ownership, accountability and teamwork with a proactive approach to quality and compliance.

📌 Senior Executive Dholka
🏢 DigiCAD
📍 Dholka