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Associate - QA

IncepBio · Posted today

  • Bengaluru, Karnataka, India (On-site)
  • Full-time
  • 0-6 yrs

About the role

Experience: 0 - 6 months(freshers)

Location: Bangalore

Industry: Pharma (Service Sector)

Key Responsibilities

  • Develop and maintain QA policies and procedures.
  • Ensure compliance with GDP, GMP, and other standards.
  • Perform internal and external audits; drive corrective actions.
  • Oversee documentation processes, including SOPs, protocols, and reports.
  • Create and deliver training programs on quality requirements.
  • Prepare and present quality reports to management.
  • Collaborate with project managers, research staff, and external partners.
  • Support regulatory submissions, inspections, and client audits.
  • Analyze quality data to identify improvement opportunities.
  • Evaluate and monitor supplier quality, coordinating with procurement and other teams.
  • Investigate customer complaint, deviations & implementing necessary corrective and preventive actions.
  • Participate in vendor audits and follow up on corrective actions.
  • Liaise with operation teams to ensure alignment of quality standards and testing procedures.
  • Provide guidance on validation methodologies and equipment qualification.
  • Lead or support change management activities related to quality systems and processes.
  • Evaluate change proposals for potential quality impacts, ensuring proper implementation.
  • Ensure that all quality systems are validated and comply with data integrity requirements.
  • Oversee the implementation and maintenance of quality-related software and technology tool

Skills

GDP, GMP complianceDocumentation management (SOPs, protocols, reports)
Associate - QA at IncepBio, Bengaluru, Karnataka, India (On-site) | Quark9