Manager/Dy Manager – CQA | Zydus Lifesciences | Ahmedabad

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Job Overview

  • Date Posted
    May 23, 2023
  • Location (State / UT)
  • Expiration date
    August 13, 2024
  • Experience
    10 Years, 15 Years
  • Gender
  • Desired Qualification
    Master’s Degree

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.