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 : 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.