Assistant General Manager

Rubicon Research Limited; Thane; On-site; INR 4,500,000 - 7,000,000; Full time

Job summary

Rubicon Research Limited in Ambernath seeks a General Manager/Asst General Manager for Quality Control to lead a 40+ member team. You will oversee analytical method validation, transfers, and incident management, with responsibility for GLP, QMS, and compliance during FDA/MHRA/EU audits.

The role requires extensive GMP experience, strong leadership, and hands-on involvement in lab automation and new lab setups. Travel to Satara/Thane may be required as per policy.

Qualifications

• Master degree in Science or Master of Pharmacy (or equivalent).
• Strong knowledge of HPLC, Dissolution, GC, IC, IR and KF water analysis.
• Experience ensuring GLP and QMS activities and audit readiness.
• Experience with GMP and US/EU audits (FDA, MHRA, etc.).
• Ability to deliver tasks with minimal supervision and drive improvements.

Responsibilities

• Lead QC team (40+ members) to achieve company goals.
• Oversee analytical method validations/verification and transfers.
• Coordinate incidents, investigations, CAPA, deviations, and change control.
• Drive automation projects (lab automation) and ensure successful implementation.
• Lead in the absence of the QC-HOD and support departmental improvements.
• Support new lab setups and audit readiness for FDA/MHRA/EU.

Skills

Leadership

Analytical skills

Problem solving

Communication

Education

Master degree in Science or Master of Pharmacy

Tools

HPLC

Dissolution

GC

IC

IR

KF (Water)

Chromeleon 7.2

Job description

Position / Job Title General Manager/Asst General Manager (Leader + Section In-Charge)

Department Quality Control

Reporting To AVP (M4)

Location Ambernath

Years of Experience 18 years +

Dosage Form Solid Oral / Nasal / Liquid

Job Responsibilities / Deliverables

• Responsible for leading the QC team size of 40+ Members with good leadership qualities to achieve company goals. He should have sound analytical knowledge and expertise in all types of modern analytical instruments like HPLC, GC, IC, PSD etc. He should have the capability of problem solving for team.
• Overall responsible for Analytical method validations/verification and transfers i.e to ensure completion of Analytical method validations/verifications/transfers in timely and compliant manner. Responsible for initiation, execution & approval of all incidents, investigations, File notes, ratification, OOS, OOT, Change Control, Deviations, CAPA etc.
• 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 QC site for work output
• Also responsible for leading any type of automation project (Eg. Lab-Automation) in Lab and actively participate to success it with ownership.
• He should be self-driven, have the capability to take self-decision and be a good learner. He should have the capability to lead all types of QC work in the absence of QC-HOD and actively participate in departmental improvement programs to enhance the Output and Quality.
• He should have experience of new lab set up.
• He should have experience of facing the FDA Audit (US, MHRA, EU) individually.
• Responsible for adherence of GLP and Health, Safety Environment system in Laboratory.
• Should have good written and communication skill and perform the task given by the HOD as and when required.

Qualifications & Pre-Requisites

• Master Degree of Science / Bachler or Master Pharma.
• Good knowledge of HPLC / Dissolution / GC / IC / IR / Water by KF.
• Responsible for ensuring completion of GLP and QMS activities.
• Knowledge of Chromeleon 7.2 software will be an added advantage.
• Should have good working experience in GMP and USFDS/EU Audit faced.
• Should have skill to achieve deliverable task with minimum support for analysis.

Additional Notes

• Role is expected to work in all shifts.
• If required he might need to travel to Satara, Thane site, on work priority as per company policy.
• Responsible for ensuring compliance to GLP, Health, Safety and Environment.