Senior Quality Manager

13 hours ago

Kannur, Kerala, India beBeeAnalytical Full time ₹ 10,00,000 - ₹ 12,50,000
Job Opportunity:

The Senior Quality Manager will oversee a large team of 30+ members in QC, including an AMV team. The primary responsibility is leading the LC-MS, Nasal analytical, FT-NIR analytical teams for regular testing/method validation activities.

Key Responsibilities:

  • Lead the QC-AMV team size of 30+ members (LC-MS, Nasal and FT-NIR team) for regular testing/method validation activities and achieve company goals using sound analytical knowledge and good leadership qualities.
  • Provide back-up support to the QC HOD with daily updates, commercial output, monthly sample status, Training, monthly review meetings and coordination with all stakeholders to align work as per requirements.
  • Execute and approve different types of QMS (OOS, OOT, Investigation etc) and identify scientific root causes with effective CAPA while maintaining Lab compliance.
  • Design and execute planning of analysis (Routine work, Method validation and Method transfer), data interpretation and present to HOD.
  • Be self-driven, make self-decisions, be a good learner and provide guidance to team members for improving work quality and monitoring and reporting 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 QA, RA, R&D and PMI to proceed allocated tasks with ownership and accountability.
  • Stay updated on industry developments and emerging trends to ensure competitiveness for LC-MS and FT-NIR techniques.
  • Ensure adherence to GLP and Health, Safety Environment system in Laboratory and face FDA Audit (US, MHRA, EU) individually.

Required Qualifications & Skills:

  • Master Degree of Science / Bachelors or Master Pharma.
  • Strong analytical knowledge and expertise in modern analytical instruments (Like: HPLC, GC, LC-MS or NIR or Nasal performance testing etc) with ability to interpret complex data and generate insights.
  • Preferable mix work experience in QC, AMV and AD departments.
  • Strong leadership skills with proven ability to motivate and develop team members.
  • Exceptional problem-solving skills and strategic mindset. Solid organisational and time management skills, with 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.
  • Able to achieve deliverable tasks with minimum support for analysis.
  • Excellent written and verbal communication skills, with ability to present findings clearly and effectively

Additional Requirements:

  • The role is expected to manage work in all shifts.
  • If required, may need to travel to Satara, Thane site, Indore site on work priority as per company policy.
  • Responsible for ensuring compliance with GLP, Health, Safety and Environment requirements.

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