AGM/ DGM – CQA | Aculife Healthcare | Sanand, Ahmedabad

Manufacturing, QA/QC/QMS/IPQA/CQA, Top Pharma Jobs
Gujarat
October 3, 2023
Full Time
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Job Overview

  • Date Posted
    October 3, 2023
  • Location (State / UT)
    Gujarat
  • Expiration date
    May 21, 2026
  • Experience
    12 Years, 22 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

Role & Responsibilities:

  • Minimum 15-22 years of experience in QA/CQA of Injectable / sterile/parenteral, ophthalmic, and/or inhalation dosage forms as per the guidelines of the regulated market
  • Should be worked in the regulatory plant only
  • Should have good experience in audit & compliance/QMS.
  • Overall responsibility for audit & compliances, training development, the activity of the organization, and all activity as a part of the requirement of RA support from the site.
  • Ensure robust & effective quality compliance for continued manufacture & supply of pharmaceutical products meeting cGMP requirements.
  • Effectively able to manage self-inspections, regulatory & customer audit management.
  • Submission of audit compliance response to the customer & regulatory agencies within defined time frames and Tracking, monitoring & verification of action items as per the audit compliance response.
  • Co-coordinating with respective cross-functional teams to ensure cGMP compliance, and regulatory compliance across the site
  • Providing required mentoring/ coaching to the technical staff of the site to ensure the cGMP compliance across all the operations of the site with a striving for continuous improvement.

Desired Candidate Profile:

  • CQA / Audit & Compliance / QMS
  • Qualification; B.Pharma, M.Pharma, MS/M.Sc
  • Experience: 12-22 Years
  • Salary: 20.00 – 35.00 L CTC/PA

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