Senior Quality Control Manager

6 days ago

Hyderabad, Telangana, India beBeeAnalytical Full time ₹ 15,00,000 - ₹ 25,00,000
Job Summary

Purpose:

Leading large teams of 30+ members in Quality Control, including the Analytical Methods Validation (AMV) team is a key requirement. The primary responsibility involves managing the LC-MS, Nasal analytical, FT-NIR analytical teams for regular testing/method validation activities.

The secondary responsibility includes back-up support to the Head of Department with daily updates, monthly sample status, Lab management, training, and co-ordination with stakeholders to align work as per requirements.

Responsibilities:

  • Lead the QC-AMV team size of 30+ members (LC-MS, Nasal and FT-NIR team) for regular testing/method validation activities using sound analytical knowledge and good leadership qualities to achieve organisational goals.
  • Provide back-up support to the Head of Department with daily update, commercial output, monthly sample status, Training, monthly review meeting and co-ordination with all stakeholders to align the work as per requirements.
  • Execute and approve different types of Quality Management System (QMS) processes (Out of Specification, Out of Trend, Investigation etc.) and identify scientific root causes with effective Corrective Action Preventive Action (CAPA) and maintain Lab compliance.
  • Design and execute planning of analysis (Routine work, Method validation and Method transfer), data interpretation and present to Head of Department.
  • Maintain self-drive, make self-decision and be a good learner. Provide guidance to team members for improving work quality and monitor/report on Key Performance Indicators (KPIs).
  • Lead all types of QC-AMV work in absence of Head of Department and actively participate in departmental improvement programs to enhance Output and Quality.
  • Collaborate and co-ordinate with cross-functional teams like Quality Assurance, Regulatory Affairs, Research and Development and Project Management Initiatives to proceed allocated task 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.
  • Adhere to Good Laboratory Practice (GLP) and Health, Safety Environment system in Laboratory and face FDA Audit (US, MHRA, EU) individually.
Requirements

Please note that the following skills are preferable but not limited:

  • 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.
  • Preferably mix work experience in Quality Control, AMV and Administrative 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 Good Manufacturing Practice 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 Notes
  • This role requires managing work in all shifts.
  • If required, travel to other sites as per company policy.
  • Ensure compliance with GLP, Health, Safety and Environment requirements.

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