Sr. No.

Job Responsibilities

1.

To follow SOP on “Central Quality - Audit and Compliance”.

1. To follow CAC monthly schedule for audit execution activity at identified sites and support functions.
1. To plan & execute additional audits/review based on management need and guidance.
1. To prepare and review audit agenda based on site performance and expected regulatory inspection at site.
1. To ensure execution of Corporate Quality Audit for quality systems as per SOP.
1. Participate in audit opening and closing meetings. To discuss audit observations with site leadership.
1. To ensure holistic compliance need/expectations for the CAC/Regulatory/GMP consultant audit findings.
1. Apprise the audit outcome to Head Technical Services, Head Central Quality and Head CAC prior to submit final report.
1. To categorize citations and submission of final report in Audit portal as per SOP
1. To prepare executive summary of audit for management escalation.
1. Timely submission of audit reports and review response to audit observations as per SOP.
1. To ensure compliance verification of identified CAC/External SME/regulatory CAPA for adequacy during periodic or verification audits and off-site review, as applicable. Report compliance status during periodic departmental & management review.
1.



To assist site for readiness during regulatory or GMP consultant inspections, as needed.
1. To review the draft response for adequacy prior to submission to regulatory/SME agency.
1. Preparation of compliance reports periodically for the respective sites for management review.
1. To participate in the departmental and management review meetings for escalation of specific issue for compliance and support.
1. To participate in Central Quality Policy preparation, review and implementation.
1. Update self with current regulatory guidance/GMP trends, current industry knowledge regarding the system and provide required inputs for strengthening the audit plan.
1. To prepare and review departmental SOPs.
1. To maintain repository of regulatory documents (report, response, & certificates) in portal and update the status in departmental/management review meetings.
1. System harmonization-Identification of need & escalation.
1. Participation in development of recent initiatives as needed.

Job Snapshot

Updated Date

09-09-2026

Job ID

JOB10648

Department

CENTRAL QUALITY

Location

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

Experience

12 - 15 Years

Employee Type

C-C8-Confirmed-HO Executive

📌 Associate Manager - Audit & Compliance (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad