Corporate Quality Assurance

6 days ago

Mumbai, Maharashtra, India RESONACLE Full time

We are seeking a highly experienced Quality Assurance leader to drive
Corporate QA initiatives
across multiple formulation manufacturing sites. The incumbent will be responsible for strengthening the company's
Audit, Compliance, and Validation/Qualification (VQ)
framework, ensuring adherence to global regulatory standards, and maintaining continuous
inspection readiness
.

This is a
strategic corporate role
requiring close coordination with site QA, manufacturing, and regulatory teams to uphold a consistent culture of quality excellence and compliance across all units.

Key Responsibilities:

  • Lead and manage
    internal and external audits
    across formulation sites (OSD, Injectables, Topicals).
  • Ensure full compliance with
    USFDA, MHRA, EU, ANVISA, TGA, and WHO
    regulatory requirements.
  • Oversee
    audit preparedness
    , inspection readiness, and CAPA effectiveness.
  • Develop and implement
    corporate QA policies, SOPs, and governance frameworks
    .
  • Review and monitor
    site-level quality metrics
    and compliance dashboards.
  • Collaborate with site QA teams to
    standardize systems
    and close quality gaps.
  • Review and approve
    validation protocols, change controls, deviations, and risk assessments
    .
  • Ensure alignment of VQ activities with
    GMP, ICH, and data integrity
    requirements.
  • Design and deliver
    training programs
    on compliance, audit management, and regulatory awareness.
  • Act as a
    corporate liaison
    during regulatory inspections and manage post-inspection communications.

Key Requirements:

  • Education:
    B.Pharm / M.Pharm / M.Sc. (Life Sciences) or equivalent.
  • Experience:
    15+ years in Corporate QA within the
    pharmaceutical formulations
    industry.
  • Proven exposure to
    global regulatory audits
    (USFDA, EU, MHRA, ANVISA, TGA).
  • Strong understanding of
    GMP, ICH, QMS, and data integrity
    principles.
  • Hands-on experience with
    CAPA systems, documentation review, and validation oversight
    .
  • Excellent
    leadership, communication, and stakeholder management
    skills.
  • Ability to travel to multiple manufacturing sites as required.

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