Senior Operations Manager

1 day ago

Shimoga, Karnataka, India beBeeAnalytical Full time ₹ 15,00,000 - ₹ 25,00,000
Job Title: Senior Operations Manager

The primary responsibility of this position is to lead a team of 30+ members in the Quality Control (QC) department, including an Analytical Method Validation (AMV) team. The role requires a strong analytical background and leadership skills to manage daily operations and ensure compliance with Good Laboratory Practice (GLP) and Health, Safety, Environment (HSE) requirements.

Key Job Responsibilities:

  1. Lead the QC-AMV team size of 30+members for regular testing/method validation activities using sound analytical knowledge and good leadership qualities to achieve company goals.
  2. Provide back-up support to the Quality Control Head of Department (HOD) with daily updates, commercial output, monthly sample status, training, monthly review meetings, and coordination with all stakeholders to align work as per requirements.
  3. Execute and approve different types of quality management systems (QMS), such as Out-of-Specification (OOS), Out-of-Trend (OOT), investigation, and corrective actions (CAPA), and maintain lab compliance.
  4. Design and execute planning of analysis (routine work, method validation, and method transfer), data interpretation, and presenting to the HOD.
  5. Be self-driven, have the capability to make self-decision, and be a good learner. Provide guidance to team members for improving work quality and monitoring and reporting on key performance indicators (KPIs).
  6. Responsible for leading 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.
  7. Collaborate and coordinate with cross-functional teams like Quality Assurance (QA), Regulatory Affairs (RA), Research and Development (R&D), and Project Management Institute (PMI) to proceed allocated tasks with ownership and accountability.
  8. Stay updated on industry developments and emerging trends to ensure competitiveness for LC-MS and FT-NIR techniques.

Required Skills and Qualifications:

  • A master's degree in science or a bachelor's/master's degree in pharmacy.
  • 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.
  • 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 organisational and time management skills, with the 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 the ability to present findings clearly and effectively.

Additional Notes:

  • The role is expected to manage work in all shifts.
  • May need to travel to other sites on work priority as per company policy.
  • Responsible for ensuring compliance with GLP, HSE, and environment requirements.

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