Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

Quality Oversight of RD Activities

Manage QA oversight of nonclinical and clinical RD studies including method development, process development, and pilot manufacturing.

Ensure compliance with applicable regulatory frameworks GLP, GMP, GCP.

Audit Inspection Management

Plan and lead internal audits of RD labs, processes, and documentation.

Support external regulatory inspections and customer audits by preparing teams and documentation.

Document Control Review

Oversee review and approval of RD SOPs, protocols, reports, and batch records to ensure accuracy and compliance.

Ensure proper document management and archiving according to quality systems.

Deviation CAPA Management

Lead investigation and root cause analysis of deviations, nonconformances, and quality incidents in RD.

Manage corrective and preventive actions CAPA and monitor their effectiveness.

Training Quality Culture

Develop and deliver training programs on QA requirements, compliance, and best practices for RD personnel.

Promote a strong quality culture emphasizing data integrity and regulatory compliance.

Risk Management

Conduct risk assessments for RD processes and support mitigation strategies to prevent quality issues.

Crossfunctional Collaboration

Collaborate with RD, regulatory affairs, manufacturing QA, and quality control to align quality standards and address compliance issues.

Audit Scope Prioritization

Determine audit focus areas based on risk, previous findings, and regulatory expectations.

Disposition of Nonconformances

Decide on acceptability and corrective actions for deviations, outofspecifications OOS, and quality incidents.

Approval of Quality Documentation

Review and approve critical RD documents ensuring compliance and completeness.

Training Needs Quality Improvements

Prioritize training topics and continuous improvement initiatives based on audit outcomes and quality trends.