Senior Analytical Quality Manager

3 days ago

Gulbarga, Karnataka, India beBeeAnalytical Full time ₹ 1,00,00,000 - ₹ 2,00,00,000
Quality Control Lead

The ideal candidate will have the ability to handle large teams of 30+ members in quality control, including analytical method validation teams. The primary responsibility will be leading the LC-MS, Nasal and FT-NIR analytical teams for regular testing/method validation activities.

The secondary responsibility will be backup support to the Quality Control Head of Department with daily updates, monthly sample status, laboratory management, training, monthly review meetings and coordination with all stakeholders to align the work as per requirements.

Responsibilities:

  • Lead the quality control analytical method validation team size of 30+ members (LC-MS, Nasal and FT-NIR team) for regular testing/method validation activities and achieve company goals with sound analytical knowledge and good leadership qualities.
  • Provide backup support to the Quality Control Head of Department with daily update, commercial output, monthly sample status, Training, monthly review meeting and coordination with all stakeholders to align the work as per requirements.
  • Execute and approve different types of Quality Management System (OOS, OOT, Investigation etc) and identify scientific root causes with effective CAPA and maintain Laboratory compliance.
  • Design and execute planning of analysis (Routine work, Method validation and Method transfer), data interpretation and present to Head of Department.
  • Make self-decision, be a good learner, provide guidance to team members for improving the work quality and monitor and report on key performance indicators (KPIs).
  • Lead all types of quality control analytical method validation work in the absence of Quality Control Head of Department and actively participate in departmental improvement programs to enhance the Output and Quality.
  • Collaborate and coordinate with cross-functional teams like Quality Assurance, Regulatory Affairs, Research and Development and Project Management to proceed the allocated task with ownership and accountability.
  • Stay updated on industry developments and emerging trends to ensure they remain competitive for LC-MS and FT-NIR techniques.
  • Maintain adherence to Good Laboratory Practice and Health Safety Environment system in Laboratory and face the FDA Audit individually.

Requirements:

  • Bachelor's or Master's degree in Science/Pharmacy.
  • Strong analytical knowledge and expertise in modern analytical instruments (HPLC, GC, LC-MS or NIR or Nasal performance testing etc) with the ability to interpret complex data and generate insights.
  • Leadership skills with proven ability to motivate and develop team members.
  • Exceptional problem-solving skills and strategic mindset. Solid organizational and time management skills, with the ability to manage multiple projects and deadlines.
  • Knowledge of Chromeleon 7.2 and Sciex software will be an added advantage.
  • Good working experience in GMP and USFDA/EU Audit faced.
  • Ability to achieve deliverable tasks with minimum support for analysis.
  • Excellent written and verbal communication skills, with the ability to present findings clearly and effectively.

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