Validation Master Plan (VMP):
Lead the preparation, review, and maintenance of the Validation Master Plan (VMP) to ensure alignment with industry standards and regulatory requirements.
Qualification/Validation Protocols:
Review and approve Qualification/Validation protocols to ensure they comply with CGMP standards and regulatory requirements.
Quality Systems Maintenance:
Ensure all quality systems are maintained according to CGMP requirements and monitor compliance across all departments.
SOP Review & Approval:
Review and approve Quality Assurance (QA) SOPs as well as SOPs from cross-functional departments to ensure consistency and regulatory compliance.
Document Review & Compliance:
Review and approve critical documents, including URS (User Requirement Specifications), Impact Assessments, FAT (Factory Acceptance Tests), DQ (Design Qualification), FDS (Functional Design Specifications), and HDS (High-Level Design Specifications).
Execution Oversight:
Ensure compliance with GDP (Valuable Documentation Practices)



and CGMP procedures during the execution of validation and qualification activities.
Quality Management System (QMS):
Initiate and review key QMS elements such as Change Controls, Deviations, and CAPA (Corrective and Preventive Actions) to ensure timely resolution of quality issues.
Validation Documentation:
Review and approve all validation documents and reports, ensuring their compliance with internal standards and regulatory requirements.
Qualification/Calibration Planning:
Oversee the review and approval of Qualification/Calibration schedules and annual plans to ensure timely execution of required activities.
Risk Assessment Participation:
Participate in Quality Risk Assessment exercises in collaboration with cross-functional teams to identify and mitigate risks.
Audit & Compliance Support:
Lead and support during regulatory audits, customer visits, and inspections to ensure facility compliance with relevant standa

📌 Quality Assurance Secunderabad
🏢 Biological E
📍 Secunderabad