Senior Quality Control Manager

2 days ago

Agra, Uttar Pradesh, India beBeeAnalytical Full time ₹ 17,50,000 - ₹ 20,97,000

Job Title: Senior Quality Control Manager

Job Description:

The successful candidate will have the ability to lead large teams (30+ members) in Quality Control, including an Analytical Method Validation team. The primary responsibility is leading the LC-MS, Nasal analytical, FT-NIR analytical teams for regular testing/method validation activities.

Key responsibilities include leading the QC-AMV team size of 30+ members (LC-MS, Nasal, and FT-NIR teams) for regular testing/method validation activities and achieving company goals with sound analytical knowledge and good leadership qualities.

Additional responsibilities include providing back-up support to the QC HOD with daily updates, commercial output, monthly sample status, training, monthly review meeting, and coordination with all stakeholders to align the work as per requirements.

Executing and approving different types of QMS (OOS, OOT, Investigation, etc.) and identifying scientific root causes with effective CAPA and maintaining Lab compliance.

Designing and executing planning of analysis (routine work, method validation, and method transfer), data interpretation, and presenting to HOD.

Self-driven with the capability to make self-decisions, being a good learner, and providing guidance to team members for improving work quality and monitoring key performance indicators (KPIs).

Leading all types of QC-AMV work in the absence of QC-HOD and actively participating in departmental improvement programs to enhance Output and Quality.

Collaborating and coordinating with cross-functional teams like QA, RA, R&D, and PMI to proceed with allocated tasks with ownership and accountability.

Staying updated on industry developments and emerging trends to ensure remaining competitive for LC-MS and FT-NIR techniques.

Maintaining adherence to GLP and Health, Safety Environment system in Laboratory and facing FDA Audit (US, MHRA, EU) individually.

Required Skills and Qualifications:

A Master Degree of Science / Bachelors or Master Pharma and preferably having strong analytical knowledge and expertise in modern analytical instruments (like: HPLC, GC, LC-MS, or NIR or Nasal performance testing, etc.) with the ability to interpret complex data and generate insights.

Preferably 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 a strategic mindset.

Solid organisational 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. Having good working experience in GMP and USFDA/EU Audit faced. 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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