Senior Laboratory Director

1 week ago

Bengaluru, Karnataka, India beBeeAnalytical Full time ₹ 15,00,000 - ₹ 20,00,000

Job Title: Quality Assurance Manager

Purpose:

The role involves leading a team of 30+ members in Quality Control, including the Analytical Method Validation (AMV) team. Primary responsibilities include leading the Liquid Chromatography Mass Spectrometry (LC-MS), Nasal analytical, and Fourier Transform Near Infrared (FT-NIR) analytical teams for regular testing and method validation activities.

Key Responsibilities:

  • Lead the QC-AMV team of 30+ members (LC-MS, Nasal, and FT-NIR teams) for regular testing/method validation activities, utilizing sound analytical knowledge and leadership skills to achieve company goals.
  • Support the Head of Quality Control by providing daily updates, commercial output, monthly sample status, training, and coordinating with stakeholders to align work with requirements.
  • Execute and approve various types of quality management system (QMS) documents (OOS, OOT, Investigation, etc.) and identify scientific root causes with effective corrective actions, maintaining laboratory compliance.
  • Design and execute analysis planning, data interpretation, and presentation to the Head of Department.
  • Make self-driven decisions, provide guidance to team members for improving work quality, and monitor and report key performance indicators (KPIs).
  • Lead all types of QC-AMV work in the absence of the Head of Quality Control and participate in departmental improvement programs to enhance output and quality.
  • Collaborate and coordinate with cross-functional teams like Quality Assurance, Regulatory Affairs, Research and Development, and Project Management to complete allocated tasks with ownership and accountability.
  • Stay updated on industry developments and emerging trends to ensure competitiveness in LC-MS and FT-NIR techniques.

Requirements & Qualifications:

Preferably have the following skills but not limited as mentioned below.

  • Masters degree in Science or Pharmacy (Bachelors/Masters in Pharma)
  • Strong analytical knowledge and expertise in modern analytical instruments (HPLC, GC, LC-MS, NIR, or Nasal performance testing) with complex data interpretation and insight generation abilities.
  • Experience in QC, AMV, and AD departments, preferably with mix work experience.
  • Leadership skills with proven ability to motivate and develop team members.
  • Exceptional problem-solving skills, strategic mindset, solid organizational, and time management skills with multiple project management capabilities.
  • Knowledge of Chromeleon 7.2 and Sciex software is an added advantage.
  • Familiarity with Good Manufacturing Practice (GMP) and regulatory audit experience.
  • Able to achieve deliverable tasks with minimal support for analysis.
  • Excellent written and verbal communication skills with clear presentation abilities.

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