Job Description Summary

The Deputy Manager – Audit Compliance (Sterile Injectables) is responsible for ensuring adherence to regulatory standards and audit requirements. This role involves managing compliance processes, preparing for audits, and driving continuous improvements in sterile manufacturing operations.

Job Description

Audit Preparation and Management: Lead and coordinate internal and external audits for sterile injectable operations, ensuring readiness and compliance with regulatory standards such as USFDA, MHRA, and other global regulatory authorities.Regulatory Compliance: Ensure all processes and documentation comply with cGMP, regulatory guidelines, and company policies, addressing any gaps promptly.Documentation and Reporting: Oversee the preparation, review, and submission of audit-related documents, including CAPA (Corrective and Preventive Actions) reports, deviations, and audit responses.Training and Awareness: Conduct training programs for employees to enhance awareness of audit standards and regulatory requirements, promoting a culture of compliance.Risk Assessment and Mitigation: Identify potential compliance risks in sterile injectable processes and recommend corrective measures to mitigate them effectively.Cross-functional Coordination: Collaborate with Quality Assurance, Quality Control, Manufacturing, and other departments to ensure alignment on compliance requirements and smooth audit processes.Continuous Improvement: Drive continuous improvement initiatives by implementing best practices and addressing recurring issues identified during audits.

Commitment to Diversity, Equity, and Inclusion:  

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.