Senior Quality Assurance Professional: Audits

2 days ago


Mumbai, Maharashtra, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Title: Quality Assurance Audit & Compliance Manager

\Key Responsibilities:\
  • \
  • Prepare and schedule audits for Suppliers with other assigned audits such as TPMs, CTLs, warehouse/Distribution centers, and service providers for new and existing sites.\
  • Conduct For Cause audits to investigate quality issues and significant events.\
  • Identify and report quality and compliance risks and gaps.\
  • Review audit responses, track CAPAs, and ensure timely audit closures.\
  • Liaise with external vendors, contractors, or suppliers to ensure that their products or services meet the organization's quality standards.\
  • Support preparation and publish Approved Supplier Lists (ASL).\
  • Ensure compliance with global and local SOPs.\
  • Develop and implement a strategic plan to improve the overall quality performance of Suppliers.\
  • Establish and maintain effective working relationships with internal stakeholders, including suppliers, operations, and quality teams.\\/ul\\Requirements:\
    • \
    • Minimum 10-15 years of experience in Quality Assurance/Quality control and diversified experience, preferably in pharmaceutical audits and compliance.\
    • Strong knowledge of GMP, regulatory guidelines, and quality systems and able to evaluate all six systems of manufacturing facilities.\
    • Experience with third-party audits and supplier qualification.\
    • Proficiency in audit documentation systems.\\/ul\\Soft Skills:\
      • \
      • Strong communication and interpersonal skills.\
      • Critical thinking and analytical ability.\
      • Conflict resolution and stakeholder collaboration.\
      • Ability to coach, mentor, and work cross-functionally.\\/ul"][],


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