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Senior Associate - QA

Senior Associate - QA

incepbio
Early Applicant
  • Posted a month ago
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Job Description

Designation : Senior Associate - QA

Experience: 4 to 5 years

Location: JP Nagar, Bangalore (Onsite)

  • 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.
  • Prepare and present quality reports to management.
  • Create and deliver training programs on quality requirements.
  • Mentor and coach team members.
  • Collaborate with project managers, research staff, and external partners.
  • Support regulatory submissions, inspections, and client audits.
  • Analyse quality data to identify improvement opportunities.
  • Lead and participate in continuous improvement projects.
  • Identify and evaluate quality risks, implementing appropriate controls and mitigation strategies.
  • Conduct risk assessments related to products, processes, and suppliers.
  • Evaluate and monitor supplier quality, coordinating with procurement and other teams.
  • 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.
  • Participate in service quality reviews, ensuring adherence to quality specifications.
  • Investigate customer complaint, deviations & implementing necessary corrective and preventive actions.
  • Ensure that all quality systems are validated and comply with data integrity requirements.
  • Oversee the implementation and maintenance of quality-related software and technology tools.
  • Ensure that all quality systems are validated and comply with data integrity requirements.

More Info

Job Type:
Industry:
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Key Skills

quality reports

QA policies and procedures

risk assessments

validation methodologies

internal and external audits

quality-related software and technology tools

documentation processes

vendor audits

continuous improvement projects

About Company

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4-5 yrs
Bengaluru, India
Skills:
change management, quality reports, QA policies and procedures, equipment qualification, Sops, validation methodologies, Gmp, quality-related software and technology tools, client audits, continuous improvement projects, GDP, Inspections, internal and external audits, protocols, training programs on quality requirements, Regulatory Submissions, vendor audits