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Deputy Manager Quality Assurance

2 months ago

Hyderabad, India Indian Immunologicals Limited Full time

The ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.

Responsibilities

  • Assist the QA Manager in developing and implementing comprehensive QA protocols specific to vaccine R&D processes.
  • Ensure all activities comply with relevant regulatory standards (e.g., FDA, EMA, GxP).
  • Conduct internal audits and monitoring to ensure adherence to QA protocols.
  • Coordinate QA activities across different departments and sites to ensure consistency and alignment with QA standards.
  • Assist in the allocation of QA resources effectively to ensure all quality checkpoints are met.
  • Identify potential quality risks and support the development of contingency plans.
  • Address quality issues promptly, working with the QA Manager to ensure minimal impact on project timelines and outcomes.
  • Collaborate with R&D, clinical, regulatory, manufacturing, and commercial teams to ensure seamless execution of QA activities.
  • Facilitate communication and collaboration among QA team members and stakeholders.
  • Assist in organizing and leading regular QA status meetings, providing updates and addressing any issues or concerns.
  • Maintain accurate and up-to-date QA documentation, including protocols, audit reports, and meeting minutes.
  • Provide regular progress reports to the QA Manager and other stakeholders.
  • Ensure all QA activities adhere to GxP guidelines and regulatory expectations, maintaining high standards of quality assurance.
  • Support the development and implementation of training programs for staff on QA best practices and regulatory requirements.
  • Identify and implement best practices and process improvements to enhance the efficiency and effectiveness of QA processes.

Qualifications

  • M.Sc./M. Pharm/MTech (Biotech/Microbiology/Biochemistry)
  • Advanced degree preferred (Ph.D.)
  • 5+ years' relevant work experience
  • Highly organized with excellent attention to detail