Senior Laboratory Operations Manager

3 days ago

Coimbatore, Tamil Nadu, India beBeeQuality Full time ₹ 15,00,000 - ₹ 25,00,000

Job Title: Assistant General Manager

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Purpose and Responsibilities:

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The ideal candidate will have the ability to lead large teams (30+ members) in QC, including an AMV team. Primary responsibilities include leading the LC-MS, Nasal analytical, FT-NIR analytical teams for regular testing/method validation activities.

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Key Job Responsibilities:

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  • Lead the QC-AMV team size of 30+ members (LC-MS, Nasal, and FT-NIR teams) for regular testing/method validation activities using sound analytical knowledge and good leadership qualities to achieve company goals.
  • Support the QC HOD with daily updates, commercial output, monthly sample status, training, and coordination with all stakeholders to ensure alignment with requirements.
  • Execute and approve different types of QMS (OOS, OOT, Investigation, etc.) and identify scientific root causes with effective CAPA to maintain Lab compliance.
  • Design and execute analysis planning (routine work, method validation, and method transfer), data interpretation, and presentation to the HOD.
  • Be self-driven, capable of making decisions independently, and a good learner. Provide guidance to team members for improving work quality and monitor/report key performance indicators (KPIs).
  • 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.
  • Collaborate and coordinate with cross-functional teams like QA, RA, R&D, and PMI to complete allocated tasks with ownership and accountability.
  • Stay updated on industry developments and emerging trends to remain competitive for LC-MS and FT-NIR techniques.
  • Ensure adherence to GLP and Health, Safety, Environment systems in the laboratory and prepare for FDA audits (US, MHRA, EU) individually.
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Qualifications & Pre-Requisites:

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A Master's Degree in Science or Bachelor's/Master's in Pharma is preferred. Key qualifications include strong analytical knowledge and expertise in modern analytical instruments (HPLC, GC, LC-MS, NIR, or Nasal performance testing) with the ability to interpret complex data and generate insights.

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Desirable Skills and Experience:

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  • Mix work experience in QC, AMV, and AD departments.
  • Strong leadership skills with a 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 is an added advantage.
  • Experience in GMP and USFDA/EU audits faced is beneficial.
  • 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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Additional Notes:

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The role requires managing work in all shifts. Travel to other sites may be required as per company policy to meet work priorities.

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