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Specialist or Lead, Quality Assurance

Quality Assurance Specialist/Lead role in Bengaluru, 5-8 years experience.
ClinChoice
On-Site
India
Undisclosed salary
Job Description

A global company is seeking a Specialist or Lead for Quality Assurance in Bengaluru. The role involves performing QA functions related to change management, CAPA, deviation, internal/external audits, risk management, innovation, and continual improvement. The candidate will understand and implement GXP requirements, facilitate investigations and CAPAs, and ensure CAPA procedures are followed.

Responsibilities include:

  • Performing QA functions related to change management, CAPA, deviation, internal/external audits, risk management, innovation, and continual improvement.
  • Understanding and implementing GXP requirements (GCP, GVP, GMP, GDocP).
  • Facilitating investigations and CAPAs, monitoring progress, and performing reviews/approvals.
  • Ensuring CAPA procedures are followed.
  • Escalating issues and involving stakeholders for resolution.
  • Reviewing evidence and approving CAPA plans and effectiveness monitoring plans.
  • Participating in governance/oversight activities.

Requirements:

  • 5 to 8 years of experience in the Life Sciences domain.
  • Experience in Quality Assurance.
  • Experience in Nonconformance management (CAPA, Deviations, Issues).
  • Knowledge in Clinical Operations (preferred).
  • GCP knowledge.
  • Stakeholder management skills.
  • Conflict resolution skills.
  • Problem-solving skills.

The role offers:

  • Opportunity to work in Quality Assurance.
  • Opportunity to work in Bengaluru.
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ClinChoice

ClinChoice is a global provider of regulatory and scientific services, specializing in preparing and submitting compliant Material Safety Data Sheets (MSDS/SDS). The company supports multinational chemical manufacturing companies, offering hazard analysis, SDS authoring, and regulatory compliance expertise across US, EU, and other international markets. ClinChoice focuses on establishing structured processes for SDS preparation, and delivers comprehensive hazard assessments and SDS phrases based on global regulatory standards. They provide mentorship and review services.

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