Site Quality Head – OSD

15 years

0 Lacs

Posted:2 months ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

About the Company

pharmaceutical manufacturing industry


Role Overview

Site Quality Head


Key Responsibilities

  • Lead and manage the complete

    Quality function (QA and QC)

    at the site
  • Ensure compliance with

    GMP, regulatory, and customer requirements

  • Oversee

    quality systems

    , including deviations, CAPAs, change controls, validations, and documentation
  • Monitor and guide all

    laboratory operations

    , including chemical, instrumentation, and microbiological testing
  • Prepare for and lead

    regulatory and customer audits

    (USFDA, MHRA, WHO-GMP, etc.)
  • Drive

    continuous improvement

    in quality processes and systems
  • Collaborate cross-functionally with production, supply chain, engineering, and regulatory teams
  • Develop and mentor the site’s QA and QC teams, fostering a strong quality culture


Key Requirements

  • B.Pharm / M.Pharm / M.Sc or equivalent in life sciences
  • Minimum

    15 years of experience

    in the pharmaceutical industry, with significant exposure to

    OSD manufacturing

  • Must be

    currently working as a Site Quality Head

    or in an equivalent leadership role
  • Proven experience managing both

    Quality Assurance and Quality Control

    functions
  • In-depth knowledge of

    GMP regulations

    , audit readiness, and global regulatory expectations
  • Strong leadership, communication, and stakeholder management skills
  • Experience in handling

    regulatory inspections

    and third-party audits

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