senior manager-Quality Control

11 - 20 years

13 - 20 Lacs

Posted:4 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

quality control operations

Key Responsibilities

Core QC Operations

  • Head

    Chemical, Microbiological, Instrumental & Molecular QC

    activities. Oversee testing of:

    Raw Materials, In-process, Stability & Finished Goods

    • IVD kits: ELISA, CLIA, FIA, Rapid, Molecular

    • Pharma: OSD, Injectables, API (as applicable)

  • Review & approve

    COA, SOPs, STPs, Specifications & Protocols

    .

Regulatory & Compliance

  • Ensure compliance with:

    GMP, GLP

    • ISO 13485 (IVD)

    • WHO-GMP / USFDA

  • Lead

    regulatory, customer & internal audits

    .

Quality Systems & Investigations

  • Handle

    OOS, OOT, Deviations, Change Control & CAPA

    .
  • Lead

    method validation, verification & transfer

    .
  • Ensure

    data integrity (ALCOA+)

    and documentation control.

Instrument & Lab Management

  • Ensure qualification & calibration of:
    • HPLC, GC, UV, FTIR

    • PCR, RT-PCR, ELISA, CLIA Analyzers

  • Ensure

    lab safety, biosafety & EHS compliance

    .

Leadership & Cross-Functional Coordination

  • Lead & develop the

    QC team

    .
  • Work with

    QA, Production, R&D, RA, SCM & Engineering

    .
  • Drive

    productivity, cost control & continuous improvement

    .

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