Chief Quality Analytics Manager

5 days ago

Jamnagar, Gujarat, India beBeeAnalytical Full time ₹ 15,00,000 - ₹ 25,00,000
Job Title

Purpose:

The role requires a strong leader to manage large teams (30+ members) in Quality Control (QC), including the Analytical Methods Validation (AMV) team. The primary responsibility is to lead the LC-MS, Nasal analytical, and FT-NIR analytical teams for regular testing/method validation activities.

Key Responsibilities:

  • Team Leadership: Lead the QC-AMV team of 30+ members (LC-MS, Nasal, and FT-NIR teams) for regular testing/method validation activities, utilizing sound analytical knowledge and leadership skills to achieve company goals.
  • Support to HOD: Provide back-up support to the QC Head of Department (HOD) with daily updates, commercial output, monthly sample status, training, monthly review meetings, and coordination with stakeholders to ensure aligned work.
  • Quality Management System (QMS): Execute and approve different types of QMS (Out-of-Specification (OOS), Out-of-Trend (OOT), Investigation, etc.) and identify scientific root causes with effective Corrective Action Preventive Action (CAPA), maintaining lab compliance.
  • Analysis Planning and Execution: Design and execute planning of analysis (routine work, method validation, and method transfer), data interpretation, and presentation to the HOD.
  • Team Development and Monitoring: Maintain self-driven behavior, make informed decisions, and be a good learner, providing guidance to team members for improving work quality and monitoring key performance indicators (KPIs).
  • Collaboration and Coordination: Lead all types of QC-AMV work in the absence of the QC-HOD and actively participate in departmental improvement programs to enhance output and quality.
  • Cross-functional Collaboration: Collaborate and coordinate with cross-functional teams like Quality Assurance (QA), Regulatory Affairs (RA), Research and Development (R&D), and Project Management Institute (PMI) to proceed with allocated tasks, taking ownership and accountability.
  • Industry Updates: Stay updated on industry developments and emerging trends to remain competitive for LC-MS and FT-NIR techniques.
  • Compliance and Audits: Ensure adherence to Good Laboratory Practice (GLP) and Health, Safety, Environment systems in the laboratory and be prepared to face FDA audits (US, MHRA, EU) individually.

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