Director of Analytical Operations

2 weeks ago

Kurnool, Andhra Pradesh, India beBeeAnalytical Full time ₹ 20,00,000 - ₹ 25,00,000

Job Title: Senior Laboratory Operations Manager

The successful candidate will oversee a team of 30+ members in Quality Control (QC), leading them in regular testing and method validation activities.

Key Responsibilities:

  • Lead the QC-AMV team for regular testing/method validation activities, utilizing analytical knowledge and leadership qualities to achieve company objectives.
  • Provide backup support to the QC Head of Department with daily updates, commercial output, monthly sample status, training, and coordination with stakeholders to ensure alignment with requirements.
  • Execute and approve quality management system (QMS) procedures, identify scientific root causes, and implement corrective actions while maintaining lab compliance.
  • Develop and execute analysis planning, data interpretation, and presentation to the Head of Department.
  • Be self-driven, make informed decisions, and be a lifelong learner. Provide guidance to team members for improving work quality and monitoring key performance indicators (KPIs).
  • Lead all types of QC-AMV work in the absence of the QC-HOD and actively participate in departmental improvement initiatives to enhance output and quality.
  • Collaborate with cross-functional teams like QA, RA, R&D, and PMI to complete allocated tasks with ownership and accountability.
  • Maintain up-to-date knowledge on industry developments and emerging trends to ensure competitiveness for LC-MS and FT-NIR techniques.
  • Adhere to Good Laboratory Practices (GLP) and Health, Safety, Environment (HSE) systems in the laboratory and prepare for FDA audits (US, MHRA, EU).

Requirements & Qualifications:

  • Master's Degree or Bachelor's/Master's in Pharmacy.
  • Strong analytical knowledge and expertise in modern analytical instruments (e.g., HPLC, GC, LC-MS, or NIR) with the ability to interpret complex data and generate insights.
  • Prior experience in QC, AMV, and AD departments.
  • Excellent leadership skills with a proven ability to motivate and develop team members.
  • Exceptional problem-solving skills and strategic thinking. Strong organizational and time management skills, with the ability to manage multiple projects and deadlines.
  • Knowledge of Chromeleon 7.2 and Sciex software is an advantage.
  • Familiarity with GMP and USFDA/EU audit regulations.
  • Ability to accomplish deliverable tasks with minimal support for analysis.
  • Superior written and verbal communication skills, with the ability to present findings clearly and effectively.

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