Associate Manager - Audit & Compliance

Darwinbox Digital Solutions Pvt. Ltd.; Bogotá ciudad; Presencial; COP 52.613.000 - 87.689.000; Jornada completa

Descripción de la vacante

Zydus Lifesciences is seeking a senior Corporate Quality Auditor to lead audits, ensure CAC/regulatory compliance, and support GMP inspections from its Corporate Quality Office in Ahmedabad. The role emphasizes audit planning, reporting, and cross-functional collaboration with site leadership.

Ideal candidates bring extensive experience in quality systems, regulatory guidance, and CAPA processes, with a proactive approach to continuous improvement and documentation control in a pharmaceutical

Formación

• Plan and execute audits to support CAC/regulatory requirements.
• Prepare and review audit agendas based on site performance.
• Ensure timely submission of audit reports and corrective actions.
• Assist sites during regulatory or GMP consultant inspections.
• Maintain regulatory document repository and portal status.
• Coordinate with Heads for audit outcomes and escalation.

Responsabilidades

• Plan and execute audits to support CAC/regulatory requirements.
• Prepare and review audit agendas based on site performance and expected regulatory inspection at site.
• Ensure execution of Corporate Quality Audit for quality systems as per SOP.
• Participate in audit opening and closing meetings and discuss observations with site leadership.
• Apprise audit outcomes to Head Technical Services, Head Central Quality and Head CAC prior to final report submission.
• Maintain repository of regulatory documents in portal and update status in management reviews.

Conocimientos

Audit management

Compliance

Regulatory knowledge

CAPA

Quality systems

SOP development

Stakeholder communication

Document control

Audit reporting

Regulatory inspections readiness

Herramientas

Audit portal

Descripción del empleo

Corporate Office|Corp. Office, Ahmedabad, Gujarat, India

12 - 15 Years

Job Description

Job Responsibilities

• 1. To follow SOP on" CentralQuality - Audit and Compliance".
• 2. To follow CACmonthly schedule for audit execution activity at identified sites and supportfunctions.
• 3. To plan &execute additional audits/review based on management need and guidance.
• 4. To prepare andreview audit agenda based on site performance and expected regulatoryinspection at site.
• 5. To ensure executionof Corporate Quality Audit for quality systems as per SOP.
• 6. Participate inaudit opening and closing meetings. To discuss audit observations with siteleadership.
• 7. To ensureholistic compliance need/expectations for the CAC/Regulatory/GMP consultantaudit findings.
• 8. Apprise the auditoutcome to Head Technical Services, Head Central Quality and Head CAC priorto submit final report.
• 9. To categorizecitations and submission of final report in Audit portal as per SOP
• 10. To prepareexecutive summary of audit for management escalation.
• 11. Timelysubmission of audit reports and review response to audit observations as perSOP.
• 12. To ensure complianceverification of identified CAC/External SME/regulatory CAPA for adequacyduring periodic or verification audits and off-site review, as applicable.Report compliance status during periodic departmental & managementreview.
• 13. To assist sitefor readiness during regulatory or GMP consultant inspections, as needed.
• 14. To review thedraft response for adequacy prior to submission to regulatory/SME agency.
• 15. Preparationofcompliance reports periodically for the respective sites for managementreview.
• 16. To participate inthe departmental and management review meetings for escalation of specificissue for compliance and support.
• 17. To participate inCentral Quality Policy preparation, review and implementation.
• 18. Update self with current regulatory guidance/GMP trends, current industryknowledge regarding the system and provide required inputs for strengthening the auditplan .
• 19. To prepare andreview departmental SOPs.
• 20. To maintain repository of regulatory documents (report, response,& certificates) in portal and update the status indepartmental/management review meetings.
• 21. System harmonization-Identification of need & escalation.
• 22. Participation in development of new initiatives as needed.

Job Snapshot

• Updated Date
• 09-09-2026
• Job ID
• JOB10648
• Division
• CENTRAL QUALITY
• Location
• Location Corporate Office|Corp. Office, Ahmedabad, Gujarat, India

At Zydus Lifesciences, w e nurture a culture of innovation, excellence, and inclusivity , driving meaningful advancement in the pharmaceutical and healthcare industries. Fueled by creativity , we constantly exploring new ways to improve patient care and expand healthcare accessibility.

Our commitment to a positive and empowering work environment has earned us recognition as one of India's Best Workplaces in Biotechnology & Pharmaceuticals.