Team Leader / Sr. Team Leader - Quality Assurance

8 - 12 years

11 - 19 Lacs

Posted:1 week ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

  • Manage day-to-day quality operations and documentation reviews related to contract/loan-license manufacturing of soft gel capsules.
  • Review and ensure timely closure of:
  • Deviations and Investigations
  • Change Controls
  • CAPAs
  • Coordinate the review of Batch Documentation, Certificates of Analysis (CoAs), and related product quality documentation.
  • Facilitate communication and resolution of quality matters between:
  • Manufacturing sites (CDMO/LL partners)
  • Internal departments (Supply Chain, QC, RA)
  • External customers (on quality queries/documentation)
  • Support management of product-specific documentation such as:
  • Specifications and Test Methods
  • Master Manufacturing Records (MMRs)
  • Packaging components and artworks
  • Track progress of quality actions and drive adherence to quality KPIs and timelines.
  • Assist in supplier qualification processes, including documentation collation and audit support.
  • Prepare for and support internal/external audits and regulatory inspections.
  • Train junior quality staff and foster a culture of compliance and continuous improvement.

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Onesource Specialty Pharma Limited logo
Onesource Specialty Pharma Limited

Pharmaceuticals

N/A

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