Senior Analytical Operations Leader

1 day ago

Udaipur, Rajasthan, India beBeeAnalytical Full time ₹ 1,80,00,000 - ₹ 2,02,50,000
Job Description

The role requires a leader to direct a team 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.

Responsibilities include:

  • Leading the QC-AMV team (LC-MS, Nasal and FT-NIR) for regular testing/method validation activities with strong analytical knowledge and leadership skills.
  • Providing back-up support to the Head of Department (HOD) with daily updates, commercial output, monthly sample status, training, and coordination with stakeholders.
  • Executing and approving different types of Quality Management Systems (QMS) (Out-of-Specification, Out-of-Trend, Investigation, etc.), identifying scientific root causes with effective Corrective Action Preventive Action (CAPA) and maintaining Laboratory compliance.
  • Designing and executing planning of analysis (Routine work, Method validation and Method transfer), data interpretation, and presenting to HOD.
  • Guiding team members to improve work quality, monitoring, and reporting key performance indicators (KPIs).
  • Leading all types of QC-AMV work in the absence of QC-HOD, participating in departmental improvement programs to enhance Output and Quality.
  • Collaborating 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 and accountability.
  • Staying updated on industry developments and emerging trends to remain competitive for LC-MS and FT-NIR techniques.
  • Ensuring adherence to Good Laboratory Practice (GLP) and Health, Safety, Environment (HSE) system in the Laboratory, facing FDA Audit (US, MHRA, EU) individually.
Required Skills and Qualifications

Desirable qualifications include a Master Degree of Science or Bachelor's/Master's in Pharmacy, with strong analytical knowledge and expertise in modern analytical instruments (HPLC, GC, LC-MS or NIR or Nasal performance testing). Experience in QC, AMV, and AD departments is preferred, along with strong leadership skills, problem-solving skills, solid organisational and time management skills.

Benefits

This position offers a challenging and rewarding career opportunity with the potential for growth and development. The ideal candidate will have excellent communication and interpersonal skills, be able to work effectively in a team environment, and possess a strong passion for delivering high-quality results.

Others

We are an equal opportunities employer and welcome applications from diverse candidates. We offer a comprehensive benefits package, including health insurance, retirement plan, and paid time off.

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