Quality Assurance Leader

1 week ago

Thiruvananthapuram, Kerala, India beBeeAnalytical Full time ₹ 12,00,000 - ₹ 17,00,000
Assistant General Manager

Job Description:

The Assistant General Manager will lead large teams in quality control, overseeing regular testing and method validation activities. This role requires a strong analytical knowledge and leadership skills to achieve company goals.

Key Responsibilities:

  • Lead the quality control team of 30+ members for regular testing and method validation activities and achieve company goals with sound analytical knowledge and leadership qualities.
  • Provide backup support to the Head of Quality Control with daily updates, commercial output, monthly sample status, training, monthly review meetings, and coordination with stakeholders.
  • Execute and approve different types of quality management systems (OOS, OOT, Investigation) and identify scientific root causes with effective corrective action while maintaining laboratory compliance.
  • Design and execute analysis planning (routine work, method validation, and method transfer), data interpretation, and presentation to the Head of Quality Control.
  • Develop self-driven leadership skills, make self-decisions, and be a good learner, providing guidance to team members for improving work quality and monitoring key performance indicators (KPIs).
  • Take ownership of all quality control work in the absence of the Head of Quality Control and actively participate in departmental improvement programs to enhance output and quality.
  • Collaborate and coordinate with cross-functional teams like Quality Assurance, Regulatory Affairs, Research and Development, and Project Management Institute to proceed with allocated tasks.
  • Stay updated on industry developments and emerging trends to remain competitive for LC-MS and FT-NIR techniques.
  • Ensure adherence to Good Laboratory Practice and Health, Safety Environment system in the laboratory and face FDA Audits individually.

Requirements:

  • Master's Degree in Science or Bachelor's/Master's in Pharmacy.
  • Strong analytical knowledge and expertise in modern analytical instruments (HPLC, GC, LC-MS, NIR, Nasal performance testing) with complex data interpretation and insight generation.
  • Mix work experience in quality control, analytical development, and regulatory affairs departments.
  • Leadership skills with proven ability to motivate and develop team members.
  • Exceptional problem-solving skills and strategic mindset, solid organisational and time management skills.
  • 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 and verbal communication skills for presenting findings clearly and effectively.

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