Manager/Dy Manager – CQA | Zydus Lifesciences | Ahmedabad

Job Description

Manager/Dy Manager – CQA (QC Audit & Compliance)

Roles and Responsibilities:

•  To review site responses to the CAC audit for adequacy & supporting exhibits in ZyACTM.
• Tracking and review of Regulatory / Corporate commitments.
• To organize compliance meetings, follow-up meetings/ communication with site and CQ Leads to discuss unresolved observations or findings.
• To present the progress in monthly reports for the site (Including ZyACTM Response of audit reports) and participation in departmental meetings.
• To ensure SOP on Corporate Audit and Compliance is followed effectively.
• To participate in need-based corporate audits and compliance verification as per schedule.
• To support the site for compliance during preparedness and follow up for updates on compliance.
• To review regulatory/external SME and other external audit responses/updates (as assigned by management) for adequacy and appropriateness.
• To participate in corporate policy preparation, review, and implementation.
• To identify and escalate specific issues to management for compliance & support.
• To maintain all portals updated (ZyACTM, CQA Calendar, Regulatory Commitment).
• Participation in the development of new initiatives.
• Preparation of monthly reports and participation in departmental meetings.
• Any other task assigned by reporting authority from time to time for enhancement of compliance.
• System harmonization-Identification of need, escalation & track for resolution.

Desired Candidate Profile:

• Candidate should have a good amount of experience in CQA (QC).
• Should have good communication, presentation, and interpersonal skills.