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Description

Head – Quality is responsible for all regional quality operations for providing strategic direction & guidance on quality system & GMP compliance and to lead all customer & regulatory audits. To monitor QA/QC teams on critical quality issues for ensuring timely & accurate product release. To ensure that finished products provided to market are as per company specification and in compliance with applicable pharmacopeias as well cGMP/GLP/ICH/USFDA/ISO guidelines.


Key Individual Accountabilities:-

  • Lead site quality teams on product quality issues and on running business requests for GMP support.
  • Lead site quality review process & direct improvement actions or compliance related issues mitigation in timely manner.
  • Review all major capex projects & support on GMP advice related to design, qualification & timely validation of products/ projects.
  • Ensure Maintenance & improvement of BU quality system defined in International policies & GSOPs through participation & contribution as reviewer.
  • Provide guidance to MT on any changing GMP requirements, which require changes in current BU implementation level.
  • Represent management in site regulatory inspections and provide support for customer audits.
  • Provide guidance to business on GMP requirements for new product clusters.
  • Oversee regular audit of regional sites (customer) and present GMP compliance status to management.


Key Shared Accountabilities:-

  • Ensuring changes proposed are reviewed for Quality aspects and ensuring compliance to legal requirements.
  • Promoting SHE culture in organization.
  • Ensuring risk analysis for each activity is done.
  • Reporting all incidents & encouraging team to report same.

Requirements

  • Post-Graduate in Science.
  • Minimum 18 years of relevant experience in Pharmaceutical industry (API industry preferred)
  • In depth knowledge of cGMP and regulatory requirements.
  • Experienced and Certified GxP auditor
  • Prior experience in similar roles with good organization.
  • International exposure and ability to manage cultural differences.
  • Ability to obtain commitment on required improvements from organization’s manufacturing sites and good communication and interpersonal skills.
  • Proven track record of executing and implementing major projects at global level Ability to execute holistic & global CAPA

Benefits

Truly global work environment.

High performance culture.

Ability to make a difference.

Best in class compensation.

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