Assistant General Manager

4 days ago

Ulhasnagar Maharashtra India, Thane Rubicon Research Limited Full time

Purpose

The prerequisite is the ability to handle large teams (30+ members) in QC, including an AMV team. The primary responsibility for leading the LC-MS, Nasal analytical, FT-NIR analytical teams for regular testing/method validation activities. The secondary is responsible for back-up support to the QC-HOD with daily updates, monthly sample status, Lab management, training, monthly review meetings and co-ordination with all stakeholders to align the work as per requirements.


Location: Ambernath, Maharashtra


Job Responsibilities:

  • Primarily responsible for leading the QC-AMV team size of 30+members (LC-MS, Nasal and FT-NIR team) for regular testing/method validation activities and with sound analytical knowledge and good leadership qualities to achieve company goals.
  • Secondary responsible for back-up support to the QC HOD 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.
  • Responsible for Execution & approval of different types of QMS (OOS, OOT, Investigation etc) and identify scientific root causes with effective CAPA and maintain Lab compliance.
  • Responsible to design and executing planning of analysis (Routine work, Method validation and Method transfer), data interpretation and presenting to HOD.
  • Should be self-driven, have the capability to make self-decision and be a good learner. Providing guidance to team members for improving the work quality and monitoring and reporting on key performance indicators (KPIs).
  • Shall be responsible for leading all types of QC-AMV work in the absence of QC-HOD and actively participate in departmental improvement programs to enhance the Output and Quality.
  • Collaborating and coordinating with cross-functional teams like QA, RA, R&D and PMI to proceed the allocated task with ownership and accountability.
  • Stay updated on industry developments and emerging trends to ensure they remain competitive for LC-MS and FT-NIR techniques.
  • Responsible for adherence to GLP and Health, Safety Environment system in Laboratory and responsible for facing the FDA Audit (US, MHRA, EU) individually.


Qualifications & Pre-Requisites

Preferably have the following skill but not limit as mentioned below.

  • Master Degree of Science / Bachelors or Master Pharma.
  • Should have 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 will be an added advantage.
  • Should have good working experience in GMP and USFDA/EU Audit faced.
  • Should have skill to achieve deliverable tasks with minimum support for analysis.
  • Should have excellent written and verbal communication skills, with the ability to present findings clearly and effectively


Additional notes

  • The role is expected to manage the work in all shifts.
  • If required he might 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. requirement.

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