Senior Analytical Operations Manager

2 weeks ago

Kolkata, West Bengal, India beBeeAnalytical Full time ₹ 9,60,000 - ₹ 12,12,000
Job Overview

The ideal candidate will be responsible for leading large teams in Quality Control, including the Analytical Methods Validation team. Primary responsibilities include overseeing LC-MS, Nasal analytical, and FT-NIR analytical teams for regular testing and method validation activities.

Secondary responsibilities include supporting the QC Head of Department with daily updates, monthly sample status, lab management, training, and coordinating with stakeholders to align work requirements.

Key Responsibilities:
  1. Lead the QC-AMV team of 30+ members (LC-MS, Nasal, and FT-NIR) for regular testing/method validation activities, utilizing sound analytical knowledge and leadership skills to achieve company goals.
  2. Support the QC HOD with daily updates, commercial output, monthly sample status, training, and coordination with stakeholders to align work requirements.
  3. Execute and approve various types of QMS (OOS, OOT, Investigation), identify scientific root causes, implement effective CAPA, and maintain lab compliance.
  4. Design and execute analysis planning (routine work, method validation, and method transfer), interpret data, and present findings to the HOD.
  5. Be self-driven, make informed decisions, and provide guidance to team members for improving work quality and monitoring key performance indicators (KPIs).
  6. 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.
  7. Collaborate and coordinate with cross-functional teams like QA, RA, R&D, and PMI to complete allocated tasks with ownership and accountability.
  8. Stay updated on industry developments and emerging trends to remain competitive in LC-MS and FT-NIR techniques.
  9. Maintain adherence to GLP and Health, Safety, Environment systems in the laboratory and represent the organization during FDA audits (US, MHRA, EU).
Requirements:
  • Possess a Master's Degree in Science or a Bachelor's/Master's in Pharma.
  • Demonstrate strong analytical knowledge and expertise in modern analytical instruments (HPLC, GC, LC-MS, NIR, Nasal performance testing, etc.) with the ability to interpret complex data and generate insights.
  • Hold mix work experience in QC, AMV, and AD departments.
  • Exhibit strong leadership skills with proven ability to motivate and develop team members.
  • Show exceptional problem-solving skills and a strategic mindset, with solid organizational and time management skills to manage multiple projects and deadlines.
  • Knowledge of Chromeleon 7.2 and Sciex software is an added advantage.
  • Demonstrate good working experience in GMP and USFDA/EU audit exposure.
  • Ability to achieve deliverable tasks with minimal support for analysis.
  • Excellent written and verbal communication skills with the ability to present findings clearly and effectively.

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