Assistant General Manager

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:

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.