Assistant Manager - QA

Job Description

We are currently seeking an Assistant Manager - QA to join our growing team. In the role you will be responsible for:

  • Planning, scheduling, conducting, and closing audits that include projects, systems, processes, vendors, etc. as assigned. Assess, compliance to applicable regulations/guidelines, customer requirements, SOPs, and project instructions/guidelines during the audit
  • Preparing for and hosting inspections and client audits, as assigned
  • Supporting with qualification, periodic surveillance, and management of vendors
  • Evaluating and effectively managing SOP deviations, quality issues, and complaints.
  • Reviewing and approving the investigations, Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), and Effectiveness Check (EC) plans.
  • Evaluating policies and procedures for compliance with applicable regulations/guidelines and provide recommendations for continuous process improvement.
  • Providing interpretations and consultation to project teams on regulations, guidelines, policies, and procedures
  • Ensuring compliance to training and conduct training to staff within and outside QA, as assigned.
  • Support the effective implementation and maintenance of Quality Management Systems
  • Lead and support with departmental activities and QA initiatives

Desirable Skills and Experience

  • QA Audits
  • Clinical Trial Audits
  • Sponsor Audits
  • Site Audits

Bangalore, India

Life Science Graduate

Manager

Quality Assurance

Full Time

10 Aug 2021