Senior Quality Leadership Specialist

1 week ago

Alwar, Rajasthan, India beBeeAnalytical Full time ₹ 15,00,000 - ₹ 20,00,000
Key to Success

Leading a team of 30+ members in Quality Control (QC), including an Analytical Method Validation (AMV) team, is crucial for success. This role requires strong analytical knowledge and leadership qualities to drive company goals forward.

Responsibilities:

  • Lead the QC-AMV team for regular testing/method validation activities using sound analytical knowledge and good leadership qualities.
  • Support the Head of Department (HOD) with daily updates, commercial output, monthly sample status, training, monthly review meetings, and coordination with stakeholders to align work as per requirements.
  • Execute and approve Quality Management System (QMS) activities such as Out of Specification (OOS), Out of Trend (OOT), Investigation, etc., and identify scientific root causes with effective Corrective Action Preventative Action (CAPA) and maintain laboratory compliance.
  • Design and execute planning of analysis (routine work, method validation, and method transfer), data interpretation, and presenting to HOD.
  • Be self-driven with the ability to make self-decision, be a good learner, provide guidance to team members for improving work quality, and monitor and report on Key Performance Indicators (KPIs).
  • Lead all types of QC-AMV work in the absence of QC-HOD and actively participate in departmental improvement programs to enhance output and quality.
  • Collaborate and coordinate 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.
  • Stay updated on industry developments and emerging trends to remain competitive for Liquid Chromatography-Mass Spectrometry (LC-MS) and Fourier Transform Near-Infrared (FT-NIR) techniques.
  • Maintain adherence to Good Laboratory Practice (GLP) and Health, Safety Environment system in Laboratory and face FDA Audit (US, MHRA, EU) individually.

Requirements & Qualifications

Prioritize the following skills and qualifications:

  • Master's Degree of Science / Bachelor's or Master's in Pharmacy.
  • Strong analytical knowledge and expertise in modern analytical instruments (High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), LC-MS, or Near-Infrared (NIR), Nasal performance testing, etc.) with the ability to interpret complex data and generate insights.
  • Mix experience in QC, AMV, and Analytical Development (AD) departments.
  • Strong leadership skills with a proven ability to motivate and develop team members.
  • Exceptional problem-solving skills and a 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 Good Manufacturing Practice (GMP) and USFDA/EU Audit faced.
  • Able 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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