Senior Team Leader

1 day ago

Bhavnagar, Gujarat, India beBeeAnalytical Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Overview:

This is a leadership role that requires a leader who can manage large teams of 30+ members in Quality Control (QC), including an Analytical Method 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.

The secondary responsibility involves backup support to the QC Head of Department (HOD) with daily updates, commercial output, monthly sample status, lab management, training, and co-ordination with stakeholders to align work according to requirements.

Key Responsibilities:

  • Lead the QC-AMV team of 30+ members (LC-MS, Nasal, and FT-NIR teams) for regular testing/method validation activities with sound analytical knowledge and leadership qualities to achieve company goals.
  • Provide backup support to the QC HOD with daily updates, commercial output, monthly sample status, training, and coordination with stakeholders to align work according to requirements.
  • Execute and approve different types of Quality Management System (QMS) issues (OOS, OOT, Investigation, etc.) and identify scientific root causes with effective Corrective Action and Preventive Action (CAPA) and maintain lab compliance.
  • Design and execute planning of analysis (routine work, method validation, and method transfer), data interpretation, and presenting findings to the HOD.
  • Maintain self-drive, make decisions independently, and be a good learner. Provide guidance to team members for improving work quality and monitor/report key performance indicators (KPIs).
  • Assume leadership of all types of QC-AMV work in the absence of QC-HOD and actively participate in departmental improvement programs to enhance output and quality.
  • Collaborate/coordinate with cross-functional teams like Quality Assurance (QA), Regulatory Affairs (RA), Research and Development (R&D), and Project Management Institute (PMI) to proceed allocated tasks with ownership/accountability.
  • Stay updated on industry developments and emerging trends to ensure competitive advantage for LC-MS and FT-NIR techniques.
  • Ensure adherence to Good Laboratory Practice (GLP) and Health, Safety Environment system in Laboratory and face FDA audits (US, MHRA, EU) individually.

Qualifications & Pre-Requisites:

  • A Master's degree in Science or Pharmacy (Bachelors or Masters).
  • Strong analytical knowledge and expertise in modern analytical instruments (High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Liquid Chromatography-Mass Spectrometry (LC-MS), Near-Infrared (NIR), Nasal performance testing, etc.) with complex data interpretation and insight generation.
  • Prior experience in QC, AMV, and AD departments (mix work experience preferred).
  • Leadership skills with proven ability to motivate/develop team members.
  • Exceptional problem-solving skills and strategic mindset. Solid organizational/time management skills with multiple project/deadline handling.
  • Knowledge of Chromeleon 7.2 and Sciex software as an added advantage.
  • Good working experience in GMP and USFDA/EU audit faced.
  • Ability to achieve deliverable tasks with minimal support for analysis.
  • Excellent written/verbal communication skills with clear/presenting findings effectively.

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