Executive - External supply Quality - Corporate Quality Assurance

Indoco Remedies

Navi Mumbai

On-site

INR 1,000,000 - 1,500,000

Full time

8 days ago

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Job summary

Indoco Remedies in Navi Mumbai seeks a Quality Assurance professional to oversee QA activities at third-party and loan license manufacturing sites, ensuring cGMP, GLP compliance and regulatory readiness.

You will review APQR, stability data and batch documentation, manage deviations, CAPA and change controls, handle market recalls and support technology transfer and continuous improvement.

Responsibilities

  • Oversee Quality Assurance activities at third-party and loan license manufacturing sites.
  • Conduct GMP audits, site qualification and periodic quality assessments.
  • Manage QMS activities, including deviations, CAPA, OOS/OOT and change controls.
  • Ensure cGMP, GLP and regulatory compliance across external manufacturing sites.
  • Review APQR, stability data, batch documentation and batch release.
  • Handle market complaints, product recalls and joint investigations.
  • Ensure regulatory audit readiness and data integrity compliance.
  • Support technology transfer, new product launches and continuous quality improvement.

Job description

Role & responsibilities
  • Oversee Quality Assurance activities at third-party and loan license manufacturing sites.
  • Conduct GMP audits, site qualification and periodic quality assessments.
  • Manage QMS activities, including deviations, CAPA, OOS/OOT and change controls.
  • Ensure cGMP, GLP and regulatory compliance across external manufacturing sites.
  • Review APQR, stability data, batch documentation and batch release.
  • Handle market complaints, product recalls and joint investigations.
  • Ensure regulatory audit readiness and data integrity compliance.
  • Support technology transfer, new product launches and continuous quality improvement.
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